Application Nr Approved Date Route Status External Links
NDA022410 None Buccal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Buprenorphine And Naloxone Sublingual Film Is Indicated For Treatment Of Opioid Dependence. Buprenorphine And Naloxone Sublingual Film Should Be Used As Part Of A Complete Treatment Plan That Includes Counseling And Psychosocial Support. Buprenorphine And Naloxone Sublingual Film Contains Buprenorphine, A Partial‐opioid Agonist, And Naloxone, An Opioid Antagonist, And Is Indicated For Treatment Of Opioid Dependence. ( 1 ) Buprenorphine And Naloxone Sublingual Film Should Be Used As Part Of A Complete Treatment Plan That Includes Counseling And Psychosocial Support. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE ZINC100373348
2. Naloxone Hydrochloride NALOXONE HYDROCHLORIDE ZINC389747

Comments