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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

NALBUPHINE

ANDANot in Orange Book

NALBUPHINE HYDROCHLORIDE | A070692 | QUAD PHARMS

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 (1)

#001 — 10MG/ML

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Injectable; Injection | Approved: N/A

No patent or exclusivity listings for this strength.