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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212756


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NDA 212756 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in eighteen NDAs. It is available from twenty-two suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE profile page.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Pharmacology for NDA: 212756
Suppliers and Packaging for NDA: 212756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 212756 ANDA INGENUS PHARMACEUTICALS, LLC 50742-364 50742-364-30 30 POUCH in 1 CARTON (50742-364-30) / 1 FILM in 1 POUCH (50742-364-01)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 212756 ANDA INGENUS PHARMACEUTICALS, LLC 50742-365 50742-365-30 30 POUCH in 1 CARTON (50742-365-30) / 1 FILM in 1 POUCH (50742-365-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCAL, SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Jun 2, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCAL, SUBLINGUALStrengthEQ 12MG BASE;EQ 3MG BASE
Approval Date:Jun 2, 2022TE:ABRLD:No

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