Is there a generic for Nandrolone phenpropionate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Nandrolone phenpropionate, referencing the brand DURABOLIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nandrolone phenpropionate?

DURABOLIN (NDA 011891, ORGANON USA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nandrolone phenpropionate are approved?

Nandrolone phenpropionate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Nandrolone phenpropionate

Nandrolone phenpropionate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DURABOLIN · NDA 011891

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DURABOLIN×2	ORGANON USA INC	NDA 011891	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
NANDROLONE PHENPROPIONATE	WATSON LABS	ANDA 086386	—	Jun 17, 1983
NANDROLONE PHENPROPIONATE	WATSON LABS	ANDA 087488	—	Jun 17, 1983

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.

Nandrolone phenpropionate — frequently asked questions

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

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