Application Nr Approved Date Route Status External Links
ANDA078633 None Sublingual None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Buprenorphine Sublingual Tablets Are Indicated For The Treatment Of Opioid Dependence And Are Preferred For Induction. Buprenorphine Sublingual Tablets Should Be Used As Part Of A Complete Treatment Plan To Include Counseling And Psychosocial Support. Under The Drug Addiction Treatment Act (Data) Codified At 21 U.s.c. 823(G), Prescription Use Of This Product In The Treatment Of Opioid Dependence Is Limited To Physicians Who Meet Certain Qualifying Requirements, And Who Have Notified The Secretary Of Health And Human Services (Hhs) Of Their Intent To Prescribe This Product For The Treatment Of Opioid Dependence And Have Been Assigned A Unique Identification Number That Must Be Included On Every Prescription. Buprenorphine Sublingual Tablets Are Indicated For The Treatment Of Opioid Dependence And Are Preferred For Induction. Prescription Use Of This Product Is Limited Under The Drug Addiction Treatment Act. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE ZINC100373348

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