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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

NANDROLONE DECANOATE

ANDA

Tentative Approval

NANDROLONE DECANOATE | A089249 | QUAD PHARMS

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 — 100MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.