Application Information

This drug has been submitted to the FDA under the reference 091149/001.

Names and composition

"BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE" is the commercial name of a drug composed of BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
091149/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
091149/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
091422/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
091422/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
201633/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
201633/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
203136/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
203136/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
203326/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
203326/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
204431/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
204431/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
205022/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
205022/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020733/001 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020733/002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
022410/001 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL, SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
022410/002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL, SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
022410/003 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL, SUBLINGUAL EQ 4MG BASE and EQ 1MG BASE
022410/004 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL, SUBLINGUAL EQ 12MG BASE and EQ 3MG BASE
091149/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
091149/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
091422/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
091422/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
201633/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
201633/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
203136/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
203136/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
203326/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
203326/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
204242/001 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 1.4MG BASE and EQ 0.36MG BASE
204242/002 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 5.7MG BASE and EQ 1.4MG BASE
204242/003 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8.6MG BASE and EQ 2.1MG BASE
204242/004 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 11.4MG BASE and EQ 2.9MG BASE
204242/005 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2.9MG BASE and EQ 0.71MG BASE
204242/006 ZUBSOLV BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 0.7MG BASE and EQ 0.18MG BASE
204431/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
204431/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
205022/001 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 2MG BASE and EQ 0.5MG BASE
205022/002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET/SUBLINGUAL EQ 8MG BASE and EQ 2MG BASE
205637/001 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL EQ 2.1MG BASE and EQ 0.3MG BASE
205637/002 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL EQ 4.2MG BASE and EQ 0.7MG BASE
205637/003 BUNAVAIL BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM/BUCCAL EQ 6.3MG BASE and EQ 1MG BASE

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