Application Nr Approved Date Route Status External Links
ANDA201633 None Sublingual None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

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