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DECA-DURABOLIN

NDA

NANDROLONE DECANOATE | N013132 | WOODWARD SPECIALTY LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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 (3)

Sort:

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 12, 1986

No patent or exclusivity listings for this strength.

#002 — 100MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1986

#003 — 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 12, 1986