Is there a generic for Gonadorelin hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gonadorelin hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Gonadorelin hydrochloride?

FACTREL (NDA 018123, HIKMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gonadorelin hydrochloride are approved?

Gonadorelin hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gonadorelin hydrochloride

Gonadorelin hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:FACTREL · NDA 018123

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
FACTREL×3	HIKMA	NDA 018123	—	Sep 30, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Gonadorelin hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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