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NALBUPHINE HYDROCHLORIDE

ANDA

NALBUPHINE HYDROCHLORIDE | A216050 | SOMERSET THERAPEUTICS LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs2 inactive

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

SPECGX LLCNALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310

DMF 114211995

FRANCOPIA A EUROAPI CONALBUPHINE HYDROCHLORIDE

DMF 211442007

SPECGX LLCNALBUPHINE HYDROCHLORIDE (1P)

DMF 236042010

MALLINCKRODT CHEMICAL INCInactiveNALBUPHINE HYDROCHLORIDE CODE 3300

DMF 28831977

SANOFI SYNTHELABO INCInactiveNALBUPHINE HYDROCHLORIDE

DMF 62791986

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

Products (2)

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#001 — 10MG/ML (10MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 19, 2024

No patent or exclusivity listings for this strength.

#002 — 20MG/ML (20MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 19, 2024