Is gonadorelin FDA-approved?

Yes as a substance, and no as anything you can obtain. Gonadorelin is the active ingredient of two FDA-approved new drug applications — NDA 018123 (Factrel, gonadorelin hydrochloride, approved 30 September 1982, classified by FDA as 'Type 1 - New Molecular Entity', now held by Hikma) and NDA 019687 (Lutrepulse Kit, gonadorelin acetate, approved 10 October 1989, 'Type 2 - New Active Ingredient', held by Ferring). Drugs@FDA lists all five products across those two applications in marketing status Discontinued, so no approved gonadorelin product for human use is marketed in the United States, and the NDC Directory contains no finished human gonadorelin product at all. Two things follow that people routinely get backwards. An approval attaches to the products described in the application, not to every vial sharing the ingredient name — FDA issued a warning letter in June 2026 stating that a product sold online as 'Gonadorelin' was an unapproved new drug. And the existence of an approval says nothing about what the approval was FOR: FDA has not published the labeling for either application, so the approved indications cannot be quoted here.

What was Factrel approved for, and why can't I find the label?

The label is not published by FDA, so this site does not state the indication. Drugs@FDA carries the approval history for NDA 018123 (Factrel, gonadorelin hydrochloride, approved 30 September 1982, fourteen supplements through July 2002) and returns the same line against every one of them: 'Label is not available on this site.' The same is true of NDA 019687 (Lutrepulse Kit). Checked on 2 August 2026, there is also no gonadorelin human label in DailyMed, none in openFDA's drug/label endpoint under either application number, and no label PDF under accessdata.fda.gov/drugsatfda_docs/label. Drug-reference sites do state indications for both products, and they may be right, but they are not FDA and this site does not requote them as though they were. One warning while you search: 'Factrel' is also the brand name of a currently marketed FDA-approved animal drug for cattle, so a search for Factrel labeling will return a document whose own text reads 'For use in animals only. Not for human use.'

Did FDA withdraw approval of gonadorelin?

No withdrawal was found, and the distinction matters. Discontinuing a product from marketing and withdrawing an application's approval are separate acts: under 21 CFR 314.150(c) FDA withdraws approval when the applicant REQUESTS withdrawal because the drug is no longer being marketed, and FDA announces such withdrawals in the Federal Register. A full-text search of FDA's Federal Register documents for 'gonadorelin', run on 2 August 2026, returns seventeen documents — every one of them a NEW ANIMAL DRUG notice. 'Lutrepulse' returns zero documents across the entire Federal Register, and the two application numbers return nothing. Both applications also still appear in the Orange Book's Discontinued Drug Product List. The honest limits: this is negative evidence, the Federal Register's full-text index begins in 1994, and FDA's own Orange Book preface says the Discontinued list can include products whose approvals were withdrawn for reasons other than safety or effectiveness. For NDA 018123 the gap cannot matter, because FDA approved a supplement to it in July 2002. This is where gonadorelin differs from sermorelin, whose GEREF approvals have an actual Federal Register withdrawal notice.

Is it legal to buy gonadorelin as a research peptide online?

FDA has treated at least one such sale as illegal. In warning letter 729447, issued 17 June 2026 after a review of the seller's website, FDA stated that the product offered as 'Gonadorelin' is an unapproved new drug under section 505(a) of the FD&C Act and that 'introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a)'. FDA's basis was the seller's own product page: the statements there showed the product was 'intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body', which makes it a drug under section 201(g)(1). Note that the page FDA quoted was written in research language — 'Investigations show how gonadorelin affects testosterone production … in experimental subjects' — and FDA reproduced that language as the evidence rather than accepting it as a disclaimer. FDA also stated 'No approved applications pursuant to section 505 of the FD&C Act … are in effect for these products', which is about the seller's products: two approved applications containing gonadorelin do exist, and neither of them describes a vial bought from a website.

Can a compounding pharmacy legally compound gonadorelin?

This record does not answer that, and the reason is worth reading, because both confident answers circulating are unsupported. FDA states that a pharmacist or physician compounding under section 503A may use a bulk drug substance only if it, in FDA's own sequence, complies with an applicable USP or NF monograph if one exists; or is a component of an FDA-approved drug product if no such monograph exists; or appears on the 503A bulks list if no monograph exists and it is not a component of an FDA-approved drug product. Two facts are established here: gonadorelin appears in none of the three categories of the 503A bulks list updated 14 May 2026, verified by extracting the document's text on 2 August 2026; and gonadorelin is the active ingredient of two approved NDAs whose products are all discontinued. What is NOT established is how the first two conditions apply — whether a USP or NF monograph exists for gonadorelin or its salts was not verified, and FDA has published no determination on whether a substance whose only approved products are discontinued counts as a component of an FDA-approved drug product. Absence from the bulks list is therefore not a prohibition, because the list is the third route and is reached only if the first two fail. Separately, section 503A is about compounding against prescriptions for identified patients; it has nothing to say about buying a research-labelled vial online.

Is the Factrel sold for cattle the same as human gonadorelin?

Same molecule, different drug product, and the labeling says so. The Factrel currently marketed in the United States is an FDA-approved ANIMAL drug from Zoetis under NADA 139-237, indicated 'For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers' and for synchronising oestrous cycles in dairy cows. Its labeling states: 'For use in animals only. Not for human use.' The human Factrel is a separate application (NDA 018123, gonadorelin hydrochloride, approved 1982), it is a different sponsor and a different formulation, and Drugs@FDA lists all of its products as Discontinued. The two share a brand name and an active ingredient and nothing else that matters. This is worth knowing because the animal label is the only FDA-approved gonadorelin labeling a member of the public can currently read, which makes it easy to mistake for the human one.

Gonadorelin

Also sold as: GnRH, gonadotropin-releasing hormone, LHRH, luteinizing hormone-releasing hormone, gonadorelin hydrochloride, gonadorelin acetate, Factrel, Lutrepulse

Gonadorelin, the synthetic form of gonadotropin-releasing hormone (GnRH), is the active ingredient of two FDA-approved new drug applications — Factrel (gonadorelin hydrochloride, NDA 018123, approved 1982-09-30) and Lutrepulse Kit (gonadorelin acetate, NDA 019687, approved 1989-10-10) — and Drugs@FDA lists every product under both applications in marketing status Discontinued, so no approved gonadorelin product for human use is marketed in the United States. No Federal Register notice withdrawing either approval was found, which is why this record says discontinued rather than withdrawn. FDA has not published the approved labeling for either application — Drugs@FDA states 'Label is not available on this site.' for every submission on both — so the approved indications are recorded here as a blank rather than taken from secondary sources. The only gonadorelin labeling FDA currently publishes belongs to approved ANIMAL drugs for cattle, one of which is also branded Factrel and states 'For use in animals only. Not for human use.' Gonadorelin appears in none of the three categories of FDA's 503A bulk drug substances list updated 2026-05-14. On 17 June 2026 FDA issued warning letter 729447 to Wholesale Peptide stating that its 'Gonadorelin' product is an unapproved new drug under section 505(a) of the FD&C Act.

Which molecule this is. Gonadorelin is the synthetic form of the native hypothalamic decapeptide itself, not an analogue of it. The FDA-approved veterinary labeling states that gonadorelin 'is the gonadotropin releasing hormone (GnRH) which is produced by the hypothalamus' and that the product 'has the identical amino acid sequence as endogenous gonadorelin'. TWO DISAMBIGUATIONS, both of which change what a claim means. (1) SALT FORM AND APPLICATION. The two human applications are not the same product: NDA 018123 (Factrel) contains gonadorelin hydrochloride, NDA 019687 (Lutrepulse Kit) contains gonadorelin acetate. They were approved seven years apart by different sponsors under different submission classifications. Anything true of one is not automatically true of the other. (2) GONADORELIN IS NOT A GnRH AGONIST ANALOGUE. Leuprolide, goserelin and triptorelin are modified, long-acting GnRH analogues with their own approvals and their own labeled effects; gonadorelin is the short-lived natural sequence. Evidence and approvals attaching to those molecules do not transfer to this one, in either direction. A third collision is purely a naming problem but trips people constantly: 'Factrel' is also the brand name of a currently marketed FDA-approved ANIMAL drug for cattle (NADA 139-237). A search for Factrel labeling returns that product, not the human one.

FDA status

FDA-approved

FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.

READ THIS ONE CAREFULLY, BECAUSE THE LABEL ON THE BADGE IS THE LEAST PRECISE THING ABOUT IT. Gonadorelin is the active ingredient of two FDA-approved new drug applications, and NEITHER HAS A MARKETED PRODUCT. Drugs@FDA lists all five products across the two applications — three Factrel presentations under NDA 018123 (original approval 1982-09-30, classification 'Type 1 - New Molecular Entity', sponsor now Hikma) and two Lutrepulse Kit presentations under NDA 019687 (original approval 1989-10-10, classification 'Type 2 - New Active Ingredient', review priority 'STANDARD; Orphan', sponsor Ferring) — every one of them in marketing status Discontinued. WHY NOT `approval-withdrawn`, WHICH IS WHAT THIS RECORD WAS EXPECTED TO SAY. Because discontinuation from marketing and withdrawal of approval are different acts and only the first is documented. Withdrawal under 21 CFR 314.150(c) requires the applicant to REQUEST it, and FDA announces such withdrawals in the Federal Register. A full-text search of FDA's Federal Register documents for 'gonadorelin' returns seventeen documents, all of them NEW ANIMAL DRUG notices; 'Lutrepulse' returns zero across the entire Federal Register; and the NDA numbers return nothing. Both applications also remain in the Orange Book's Discontinued Drug Product List as of the data file read on 2026-08-02. This is the compound where sermorelin's pattern does NOT repeat: sermorelin's GEREF NDAs have an actual withdrawal notice (74 FR 23407), and gonadorelin's do not. THE LIMIT OF THAT REASONING, stated rather than hidden. It is negative evidence. The Federal Register's full-text index begins in 1994. For NDA 018123 that gap cannot matter — FDA approved a supplement to it in July 2002, so any withdrawal is necessarily inside the indexed period. For NDA 019687 the last recorded FDA action is 1993-12-02, leaving a theoretical four-week window at the end of 1993. And FDA's own Orange Book preface says the Discontinued list can include products that 'have had their approvals withdrawn for other than safety or effectiveness reasons subsequent to being discontinued from marketing', so presence on that list is corroborating rather than conclusive. If a withdrawal notice for either application surfaces, this field becomes `approval-withdrawn` and the note becomes the correction. WHAT NOBODY SHOULD TAKE FROM THE WORD `approved`: that an approved gonadorelin product for human use can be obtained. None is marketed, none is listed in the NDC directory as a finished human drug, and FDA has not published the approved labeling for either application.

Drugs@FDA — applications containing gonadorelin (openFDA drug/drugsfda) — FDA, 31 July 2026

“"application_number": "NDA018123" … "brand_name": "FACTREL" … "name": "GONADORELIN HYDROCHLORIDE" … "marketing_status": "Discontinued" … "application_number": "NDA019687" … "brand_name": "LUTREPULSE KIT" … "name": "GONADORELIN ACETATE" … "marketing_status": "Discontinued"”

Checked against the source on 2 August 2026.

Evidence

Not yet verified

We have not finished verifying this against primary sources yet, so we are not going to tell you.

We have not verified this yet.

Not assigned, and the reason is specific rather than a shrug. The normal shortcut for an FDA-approved drug is to read the pivotal trials out of the label — here that shortcut does not exist, because THE LABEL DOES NOT EXIST IN PUBLIC. Drugs@FDA returns 'Label is not available on this site.' against the 1982 original approval of NDA 018123 and against every one of its fourteen supplements, and the same against the 1989 original approval of NDA 019687 and all of its supplements. Checked on 2026-08-02: openFDA's drug/label endpoint returns NOT_FOUND for both application numbers and for the substance names, DailyMed holds no human gonadorelin SPL (its five gonadorelin labels are all animal drugs), and no label PDF exists for either application under accessdata.fda.gov/drugsatfda_docs/label. So we cannot name the pivotal trials, which means we cannot open them, which means we cannot run the administration check this site requires before assigning any tier. There is a large published human literature in which GnRH was administered to people, and on its face gonadorelin looks like an easy 'proven-in-humans'. It is not being assigned on its face. An approval is evidence that FDA once saw adequate and well-controlled evidence for a SPECIFIC indication in a SPECIFIC population, and with the indication itself unrecoverable there is nothing here to scope a tier to. The blank is the honest answer until the pivotal studies are identified and opened one by one.

We would rather leave this blank than guess. Filling it with something plausible is what the rest of this category does.

What FDA actually approved

Application: NDA 018123 (Factrel, gonadorelin hydrochloride, sponsor Hikma, approved 1982-09-30); NDA 019687 (Lutrepulse Kit, gonadorelin acetate, sponsor Ferring, approved 1989-10-10) — Factrel, Lutrepulse Kit (discontinued)
Approved indication: NOT RECOVERABLE FROM A PRIMARY SOURCE — recorded as a sourced blank rather than filled in from drug-reference sites. FDA has not published the approved labeling for either application. The Drugs@FDA record for NDA 018123 states, verbatim, 'Label is not available on this site.' against the original 1982 approval and against every one of its fourteen supplements, and the record for NDA 019687 states the same against its original 1989 approval and all of its supplements. What Drugs@FDA does record is the product identity and history: FACTREL, gonadorelin hydrochloride, INJECTABLE;INJECTION, three presentations, marketing status Discontinued, original approval 09/30/1982, submission classification 'Type 1 - New Molecular Entity', review priority PRIORITY; and LUTREPULSE KIT, gonadorelin acetate, INJECTABLE;INJECTION, two presentations, marketing status Discontinued, original approval 10/10/1989, classification 'Type 2 - New Active Ingredient', review priority 'STANDARD; Orphan'. The indications repeated across the secondary corpus for both products may well be accurate; they are not sourced to FDA, and this record will not quote them as if they were.
On the discontinuation: Discontinued from marketing, which is NOT the same as withdrawn from approval. No Federal Register notice withdrawing either approval was found (see the fdaStatus note for the search and its limits). FDA's Orange Book preface describes the Discontinued Drug Product List as covering approved products that 'have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or effectiveness reasons subsequent to being discontinued from marketing' — a list that deliberately mixes several situations, so membership in it is corroboration and not proof. Nothing in any document read for this record attributes either discontinuation to a safety or effectiveness finding; equally, no FDA determination to that effect was found, and the preface notes such determinations are only reflected in the Orange Book from 1995 onward. A discontinuation with no stated reason is a blank, not an endorsement.

This is the field that normally carries the most valuable sentence on an approved-drug record — the gap between what FDA approved and what the compound is sold for. Here it carries a hole instead, and the hole is worth more than a confident paraphrase would be. Gonadorelin is marketed today alongside testosterone therapy, and the seller claims FDA quoted in the 2026 warning letter below are about testosterone production and spermatogenesis. Whether the 1982 and 1989 approvals have anything to do with those uses cannot be answered from FDA's own published record, because FDA has not published it. TWO SOURCES, ONE FIELD: the quote above is from the NDA 018123 page; the identical statement on the NDA 019687 page is recorded separately under fdaFindings so that a two-application claim is carried by two application pages. The `date` on both pages is the last FDA action each documents, because the pages carry no publication date of their own.

Drugs@FDA: FDA-Approved Drugs — New Drug Application (NDA) 018123, FACTREL — FDA, 19 July 2002

“Label is not available on this site.”

Checked against the source on 2 August 2026.

What FDA found

FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.

FDA has stated that the product sold as 'Gonadorelin' by Wholesale Peptide is an unapproved new drug under section 505(a) of the FD&C Act, and that introducing or delivering it for introduction into interstate commerce violates sections 301(d) and 505(a).
The reasoning matters more than the conclusion, and it is the reasoning that generalises past this one seller. FDA's finding is not that the molecule is unapproved in the abstract — it is that THIS PRODUCT is a new drug, because the seller's own website made it one. FDA's stated basis is that the products 'are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body', citing the intended-use regulation at 21 CFR 201.128, and that 'No approved applications pursuant to section 505 of the FD&C Act … are in effect for these products'. Read that last clause precisely: it is about the seller's products, not about the substance. Two approved applications containing gonadorelin do exist, as this record documents — but an approval covers the product described in the application, not every vial that shares an ingredient name. That is the same structure as the salt-form and research-vial problems elsewhere on this site.
Wholesale Peptide — Warning Letter, reference number 729447 — FDA, 17 June 2026
“Based on our review, “Prostamax” and “Gonadorelin” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).”
Checked against the source on 2 August 2026.
FDA identified statements on the seller's own gonadorelin product page as evidence of intended use, including: 'Spermatogenesis Research: Investigations show how gonadorelin affects testosterone production and supports testes function in experimental subjects.' and a passage describing exploration of 'applications in cancer research, particularly in hormone-dependent cancers'.
Recorded because it documents what actually triggered the letter, and because the phrasing is instructive. The page was written in a research-literature register — 'investigations', 'experimental subjects', 'laboratory settings' — and FDA reproduced it as the evidence of intended use anyway. The research voice is the exhibit, not the defence. This is the third time in 2026 that FDA has declined to treat research framing as a disclaimer that changes what a product is.
Wholesale Peptide — Warning Letter, reference number 729447 — FDA, 17 June 2026
““Spermatogenesis Research: Investigations show how gonadorelin affects testosterone production and supports testes function in experimental subjects.””
Checked against the source on 2 August 2026.
The Drugs@FDA record for NDA 019687 (Lutrepulse Kit, gonadorelin acetate) states 'Label is not available on this site.' against the original 1989 approval and against every supplement, and lists both products in marketing status Discontinued.
The second application's page, recorded separately so the record's two-application framing is carried by two documents rather than one. Two details on this page are worth keeping: the original approval is classified 'Type 2 - New Active Ingredient' and its review priority line reads 'STANDARD; Orphan', which is FDA recording an orphan designation on the application. An orphan designation is a statement about the size of the treated population, not about the strength of the evidence.
Drugs@FDA: FDA-Approved Drugs — New Drug Application (NDA) 019687, LUTREPULSE KIT — FDA, 2 December 1993
“Label is not available on this site.”
Checked against the source on 2 August 2026.
Gonadorelin appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.
Verified by downloading the PDF with a browser user-agent and extracting the text locally on 2026-08-02: zero hits for 'gonadorelin', and zero for 'GnRH', 'gonadotropin' and 'luteinizing' as well, so it is not hiding under a synonym. Recorded to close a misreading rather than to assert a status, and the misreading runs in BOTH directions here. Absence from this list is not permission and it is not a safety finding. It is also not a prohibition: the 503A bulks list is only the THIRD of three statutory routes for a bulk drug substance, and it is reached only when the first two do not apply — see the next finding, where FDA states the sequence in its own words. Gonadorelin's absence here means something categorically different from BPC-157's absence, which followed a withdrawn nomination.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.
FDA has stated that state-licensed physicians and pharmacists compounding under section 503A may only compound using bulk drug substances that comply with an applicable USP or NF monograph if one exists and the USP chapter on pharmacy compounding; are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or appear on the 503A bulks list if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.
Recorded here because it is the finding that makes the approved-versus-withdrawn distinction at the top of this record carry weight rather than being a technicality. The three conditions are SEQUENTIAL, and the second one turns on being a component of an FDA-approved drug product. WHAT THIS RECORD DOES NOT DO IS APPLY THAT TEST. Whether a substance whose only approved products are discontinued is a 'component of an FDA-approved drug product' for this purpose is a question FDA has not answered for gonadorelin in any document found on 2026-08-02, and it is not one an editor should answer on FDA's behalf. Nor is the monograph question resolved here: whether a USP or NF monograph exists for gonadorelin or its salts was not verified, and it is the FIRST condition, so it governs. The whole of what this record establishes is the sequence and the absence from the list. Anyone reading either as a green light or a red light is reading something that is not there. Note also the scope: section 503A concerns compounding by licensed pharmacists and physicians against prescriptions for identified patients. It has nothing to say about the sale of research-labelled vials, which is what the warning letter above is about.
Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — FDA, 14 May 2026
“State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that: Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding; Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or Appear on FDA's list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.”
Checked against the source on 2 August 2026.
The only gonadorelin products with current FDA-approved labeling published in DailyMed are approved ANIMAL drugs — Factrel (Zoetis, NADA 139-237), Cystorelin, Fertagyl, GonaBreed and Ovacyst. The Factrel animal labeling states: 'For use in animals only. Not for human use.'
The naming collision is not trivia — it is the reason a search for 'Factrel label' returns a cattle drug, and the reason someone can find an FDA-approved gonadorelin label and believe they have found the human one. The animal Factrel labeling is indicated 'For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers' and for oestrous synchronisation in dairy cows. It is a different application (a NADA, not an NDA), a different sponsor, a different strength and a different species. The description section of that same label is also the best public FDA statement of what the molecule is, and is quoted in this record's molecule note for exactly that reason — an animal label is a fine source for chemistry and a worthless source for human effects.
FACTREL (gonadorelin hydrochloride) injection, Zoetis Inc. — FDA-approved animal drug labeling — DailyMed (U.S. National Library of Medicine), 18 June 2026
“For use in animals only. Not for human use.”
Checked against the source on 2 August 2026.
The NDC Directory contains no finished human drug product with the generic name gonadorelin. Every gonadorelin entry is a BULK INGREDIENT listing by an active pharmaceutical ingredient manufacturer, none of which carries an application number.
Queried on 2026-08-02: thirteen listings, all product type BULK INGREDIENT, from API suppliers including Bachem, Polypeptide Laboratories, Piramal, Aspen Oss, Darmerica and several Chinese manufacturers, with marketing start dates running from 1993 to 2026. TWO OPPOSITE MISREADINGS TO AVOID. This is not evidence that gonadorelin API is approved — an NDC listing is a registration and listing act under section 510, not an approval, and the entries carry no application number precisely because there is no application behind them. Nor is it evidence that the API is illicit; registering and listing is what a compliant supplier is supposed to do. What it establishes is narrower and more useful: a live, FDA-registered supply chain for the raw substance exists in 2026 while no finished human product does.
NDC Directory — listings with generic name gonadorelin (openFDA drug/ndc) — FDA, 31 July 2026Checked against the source on 2 August 2026.
FDA describes the Orange Book's Discontinued Drug Product List as 'a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or effectiveness reasons subsequent to being discontinued from marketing'. Both gonadorelin applications appear in that list.
Recorded because it is the caveat on this record's own central claim, and leaving it in a note would mean asserting a limitation with no document behind it. The Orange Book data file downloaded on 2026-08-02 carries all five gonadorelin products with the DISCN flag: three FACTREL entries under application 018123 (Hikma) and two LUTREPULSE KIT entries under 019687 (Ferring). FDA's own definition of the list mixes several situations, one of which IS a withdrawn approval — so this listing corroborates the `approved` status but cannot establish it alone. The Federal Register search does the load-bearing work; this document says why that second check was necessary. FDA also notes on the same page that Federal Register determinations about whether a product was withdrawn for safety or effectiveness reasons are only reflected in the Orange Book from 1995 onward, so no such annotation appears on these entries either way.
Orange Book Preface — Approved Drug Products with Therapeutic Equivalence Evaluations — FDA, 15 January 2026
“a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or effectiveness reasons subsequent to being discontinued from marketing (Discontinued Drug Product List).”
Checked against the source on 2 August 2026.
Under 21 CFR 314.150(c), FDA withdraws approval of an application because a drug is no longer being marketed only when the APPLICANT REQUESTS that withdrawal: 'FDA will withdraw approval of an application or abbreviated application if the applicant requests its withdrawal because the drug subject to the application or abbreviated application is no longer being marketed…'
The regulation that makes 'discontinued' and 'withdrawn' genuinely different rather than two words for the same event. Withdrawal is an affirmative act with a trigger — an applicant's written request — and it does not follow automatically from a product leaving the market. That is why this record treats the absence of a withdrawal notice as meaningful rather than as a filing gap. Note the last clause of the quoted sentence, which is doing quiet work: this route is available only when none of the safety or effectiveness grounds in paragraphs (a) and (b) applies. The same section elsewhere provides that where FDA and an applicant agree to a withdrawal, the agency withdraws approval 'in a notice published in the Federal Register'. `date` on this source is the section's last amendment (64 FR 402, Jan. 5, 1999), not the date we read it.
21 CFR 314.150 — Withdrawal of approval of an application or abbreviated application — Office of the Federal Register (eCFR), 5 January 1999
“FDA will withdraw approval of an application or abbreviated application if the applicant requests its withdrawal because the drug subject to the application or abbreviated application is no longer being marketed, provided none of the conditions listed in paragraphs (a) and (b) of this section applies to the drug.”
Checked against the source on 2 August 2026.
FDA approved a supplement to NDA 018123 (Factrel, gonadorelin HCl) on 19 July 2002, twenty years after the original approval, stating: 'We have completed the review of this supplemental application, and it is approved.'
A small document with one important job on this record: it fixes a floor under the search window. NDA 018123 was demonstrably an approved application in July 2002, so any withdrawal of it must postdate 2002 — which places it inside the Federal Register's full-text index, where nothing was found. Without this letter the negative search result would be much weaker, because a pre-1994 withdrawal could not be ruled out. The letter also records the details Drugs@FDA compresses: the applicant was Wyeth Pharmaceuticals, the supplement covered a change in the site of manufacture, packaging, testing and release of the diluent, and the review sat with the Division of Reproductive and Urologic Drug Products. The same reasoning is NOT available for NDA 019687, whose last recorded action is 1993-12-02.
NDA 18-123/SCS-014 approval letter, Factrel (gonadorelin HCl) — FDA, 19 July 2002
“We have completed the review of this supplemental application, and it is approved.”
Checked against the source on 2 August 2026.

Documented safety signals

FDA has stated that products of this kind are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users, since injectables are delivered directly into the body, sometimes directly into the bloodstream, and therefore bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
FDA wrote this about the specific products in the letter, one of which was sold as gonadorelin. Note what the concern is ABOUT: it is a route-and-sterility argument, not a pharmacological finding about the molecule. It applies to an unapproved injectable whatever is in the vial, which is the point — with no approval, no label and no released batch record, sterility and identity are assertions by the seller.
Wholesale Peptide — Warning Letter, reference number 729447 — FDA, 17 June 2026
“These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body's key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.”
Checked against the source on 2 August 2026.
No FDA-approved human prescribing information for gonadorelin is publicly available, so there is no published set of contraindications, warnings, precautions or adverse reactions from either approved application. FDA's Drugs@FDA record returns 'Label is not available on this site.' for every submission on both NDA 018123 and NDA 019687.
Recorded as a safety signal rather than buried as an administrative footnote, because the absence has a consequence. On every other approved compound in this library the labeled contraindications are the screening questions a purchaser of an unapproved vial is never asked. Here nobody can ask them, because the questions are not published. That is a statement about the public record and not about the molecule: an unavailable label is not evidence of a benign safety profile, and it is not evidence of a bad one either.
Drugs@FDA: FDA-Approved Drugs — New Drug Application (NDA) 018123, FACTREL — FDA, 19 July 2002
“Label is not available on this site.”
Checked against the source on 2 August 2026.

Questions people actually ask

Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.

Is gonadorelin FDA-approved?: Yes as a substance, and no as anything you can obtain. Gonadorelin is the active ingredient of two FDA-approved new drug applications — NDA 018123 (Factrel, gonadorelin hydrochloride, approved 30 September 1982, classified by FDA as 'Type 1 - New Molecular Entity', now held by Hikma) and NDA 019687 (Lutrepulse Kit, gonadorelin acetate, approved 10 October 1989, 'Type 2 - New Active Ingredient', held by Ferring). Drugs@FDA lists all five products across those two applications in marketing status Discontinued, so no approved gonadorelin product for human use is marketed in the United States, and the NDC Directory contains no finished human gonadorelin product at all. Two things follow that people routinely get backwards. An approval attaches to the products described in the application, not to every vial sharing the ingredient name — FDA issued a warning letter in June 2026 stating that a product sold online as 'Gonadorelin' was an unapproved new drug. And the existence of an approval says nothing about what the approval was FOR: FDA has not published the labeling for either application, so the approved indications cannot be quoted here.
Drugs@FDA — applications containing gonadorelin (openFDA drug/drugsfda) — FDA, 31 July 2026
“"application_number": "NDA018123" … "brand_name": "FACTREL" … "marketing_status": "Discontinued" … "application_number": "NDA019687" … "brand_name": "LUTREPULSE KIT" … "marketing_status": "Discontinued"”
Checked against the source on 2 August 2026.
What was Factrel approved for, and why can't I find the label?: The label is not published by FDA, so this site does not state the indication. Drugs@FDA carries the approval history for NDA 018123 (Factrel, gonadorelin hydrochloride, approved 30 September 1982, fourteen supplements through July 2002) and returns the same line against every one of them: 'Label is not available on this site.' The same is true of NDA 019687 (Lutrepulse Kit). Checked on 2 August 2026, there is also no gonadorelin human label in DailyMed, none in openFDA's drug/label endpoint under either application number, and no label PDF under accessdata.fda.gov/drugsatfda_docs/label. Drug-reference sites do state indications for both products, and they may be right, but they are not FDA and this site does not requote them as though they were. One warning while you search: 'Factrel' is also the brand name of a currently marketed FDA-approved animal drug for cattle, so a search for Factrel labeling will return a document whose own text reads 'For use in animals only. Not for human use.'
Drugs@FDA: FDA-Approved Drugs — New Drug Application (NDA) 018123, FACTREL — FDA, 19 July 2002
“Label is not available on this site.”
Checked against the source on 2 August 2026.
Did FDA withdraw approval of gonadorelin?: No withdrawal was found, and the distinction matters. Discontinuing a product from marketing and withdrawing an application's approval are separate acts: under 21 CFR 314.150(c) FDA withdraws approval when the applicant REQUESTS withdrawal because the drug is no longer being marketed, and FDA announces such withdrawals in the Federal Register. A full-text search of FDA's Federal Register documents for 'gonadorelin', run on 2 August 2026, returns seventeen documents — every one of them a NEW ANIMAL DRUG notice. 'Lutrepulse' returns zero documents across the entire Federal Register, and the two application numbers return nothing. Both applications also still appear in the Orange Book's Discontinued Drug Product List. The honest limits: this is negative evidence, the Federal Register's full-text index begins in 1994, and FDA's own Orange Book preface says the Discontinued list can include products whose approvals were withdrawn for reasons other than safety or effectiveness. For NDA 018123 the gap cannot matter, because FDA approved a supplement to it in July 2002. This is where gonadorelin differs from sermorelin, whose GEREF approvals have an actual Federal Register withdrawal notice.
Federal Register full-text search — FDA documents mentioning gonadorelin — Office of the Federal Register, 2 August 2026
“New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship”
Checked against the source on 2 August 2026.
Is it legal to buy gonadorelin as a research peptide online?: FDA has treated at least one such sale as illegal. In warning letter 729447, issued 17 June 2026 after a review of the seller's website, FDA stated that the product offered as 'Gonadorelin' is an unapproved new drug under section 505(a) of the FD&C Act and that 'introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a)'. FDA's basis was the seller's own product page: the statements there showed the product was 'intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body', which makes it a drug under section 201(g)(1). Note that the page FDA quoted was written in research language — 'Investigations show how gonadorelin affects testosterone production … in experimental subjects' — and FDA reproduced that language as the evidence rather than accepting it as a disclaimer. FDA also stated 'No approved applications pursuant to section 505 of the FD&C Act … are in effect for these products', which is about the seller's products: two approved applications containing gonadorelin do exist, and neither of them describes a vial bought from a website.
Wholesale Peptide — Warning Letter, reference number 729447 — FDA, 17 June 2026
“Based on our review, “Prostamax” and “Gonadorelin” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).”
Checked against the source on 2 August 2026.
Can a compounding pharmacy legally compound gonadorelin?: This record does not answer that, and the reason is worth reading, because both confident answers circulating are unsupported. FDA states that a pharmacist or physician compounding under section 503A may use a bulk drug substance only if it, in FDA's own sequence, complies with an applicable USP or NF monograph if one exists; or is a component of an FDA-approved drug product if no such monograph exists; or appears on the 503A bulks list if no monograph exists and it is not a component of an FDA-approved drug product. Two facts are established here: gonadorelin appears in none of the three categories of the 503A bulks list updated 14 May 2026, verified by extracting the document's text on 2 August 2026; and gonadorelin is the active ingredient of two approved NDAs whose products are all discontinued. What is NOT established is how the first two conditions apply — whether a USP or NF monograph exists for gonadorelin or its salts was not verified, and FDA has published no determination on whether a substance whose only approved products are discontinued counts as a component of an FDA-approved drug product. Absence from the bulks list is therefore not a prohibition, because the list is the third route and is reached only if the first two fail. Separately, section 503A is about compounding against prescriptions for identified patients; it has nothing to say about buying a research-labelled vial online.
Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — FDA, 14 May 2026
“State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that: Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the United States Pharmacopeia chapter on pharmacy compounding; Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or Appear on FDA's list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.”
Checked against the source on 2 August 2026.
Is the Factrel sold for cattle the same as human gonadorelin?: Same molecule, different drug product, and the labeling says so. The Factrel currently marketed in the United States is an FDA-approved ANIMAL drug from Zoetis under NADA 139-237, indicated 'For the treatment of ovarian follicular cysts in lactating dairy cows, beef cows, and replacement dairy and beef heifers' and for synchronising oestrous cycles in dairy cows. Its labeling states: 'For use in animals only. Not for human use.' The human Factrel is a separate application (NDA 018123, gonadorelin hydrochloride, approved 1982), it is a different sponsor and a different formulation, and Drugs@FDA lists all of its products as Discontinued. The two share a brand name and an active ingredient and nothing else that matters. This is worth knowing because the animal label is the only FDA-approved gonadorelin labeling a member of the public can currently read, which makes it easy to mistake for the human one.
FACTREL (gonadorelin hydrochloride) injection, Zoetis Inc. — FDA-approved animal drug labeling — DailyMed (U.S. National Library of Medicine), 18 June 2026
“For use in animals only. Not for human use.”
Checked against the source on 2 August 2026.