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Last Updated: November 22, 2024

NANDROLONE DECANOATE - Generic Drug Details


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What are the generic sources for nandrolone decanoate and what is the scope of freedom to operate?

Nandrolone decanoate is the generic ingredient in two branded drugs marketed by Woodward Specl, Abraxis Pharm, Am Regent, Epic Pharma Llc, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for nandrolone decanoate.

Summary for NANDROLONE DECANOATE
Recent Clinical Trials for NANDROLONE DECANOATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandPhase 2
Medical Research Agency, PolandPhase 2
King Edward Medical UniversityN/A

See all NANDROLONE DECANOATE clinical trials

US Patents and Regulatory Information for NANDROLONE DECANOATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NANDROLONE DECANOATE nandrolone decanoate INJECTABLE;INJECTION 086598-001 Jan 13, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abraxis Pharm NANDROLONE DECANOATE nandrolone decanoate INJECTABLE;INJECTION 088290-001 Oct 3, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs NANDROLONE DECANOATE nandrolone decanoate INJECTABLE;INJECTION 088128-001 Dec 5, 1983 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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