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NALBUPHINE

ANDA

NALBUPHINE HYDROCHLORIDE | A070751 | ABRAXIS PHARMACEUTICAL PRODUCTS

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Sterling Winthrop, Inc. - Citizen Petition FDA-1992-P-0380 · 4 docket documents Sterling Winthrop Inc. submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval of ANDA 72-960 for Nalbuphine Hydrochloride Injection USP 20 mg in a 2 mL Carpuject sterile cartridge needle-unit, which differs in packaging configura	Other	2010-09-17	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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: Jul 2, 1986

No patent or exclusivity listings for this strength.

#002 — 100MG/10ML (10MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Jul 2, 1986