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NALBUPHINE HYDROCHLORIDE

ANDA

NALBUPHINE HYDROCHLORIDE | A070914 | HOSPIRA INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Teligent Pharma, Inc. FDA-2017-P-3675 Teligent Pharma, Inc. filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Nalbuphine Hydrochloride Injection ANDAs 070914, 070915, 070916, and 070918 held by Hospira, Inc. as a second reference-listed drug product, citing the	505(q)	2017-06-13	Denied	Teligent Pharma

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 (1)

#001 — 10MG/ML (10MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Feb 3, 1989

No patent or exclusivity listings for this strength.