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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 PHENPROPIONATE

ANDA

Tentative Approval

NANDROLONE PHENPROPIONATE | A089298 | QUAD PHARMS

API Supply Chain0 active DMFs2 inactive

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

SCHERING AGInactiveNANDROLONE PHENPROPIONATE

DMF 44821982

STEROID SRLInactiveNANDROLONE PHENPROPIONATE USP

DMF 63791986

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

Products (1)

#001 — 50MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.