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NANDROLONE DECANOATE

ANDA

NANDROLONE DECANOATE | A088128 | WATSON LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from PharmaForce, Inc. FDA-2009-P-0663 PharmaForce, Inc. submitted a citizen petition on December 30, 2008, pursuant to 21 CFR 10.30 and 314.161, requesting that the FDA determine whether Nandrolone Decanoate Injection, USP, 200 mg/mL (ANDA No. 88-128) sponsored by Watson Laboratories Inc., was voluntarily withdrawn from sale for safety	Other	2009-01-05	Withdrawn	PharmaForce

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ASPEN OSS BVNANDROLONE DECANOATE

DMF 217622008

ORMA ISTITUDO TERAPEUTICOInactiveNANDROLONE DECANOATE

DMF 32291978

GEDEON RICHTER LTDInactiveNANDROLONE DECANOATE

DMF 35031979

SCHERING AGInactiveNANDROLONE DECANOATE

DMF 41021981

STEROID SRLInactiveNANDROLONE DECANOATE (USAN)

DMF 42281981

RELIANCE LIFE SCIENCES PVT LTDInactiveNANDROLONE DECANOATE USP

DMF 248832011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 200MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 5, 1983

No patent or exclusivity listings for this strength.