Application Nr Approved Date Route Status External Links
ANDA078633 2009-10-08 Sublingual RX 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 Is Preferred For Induction. Prescription Use Of This Product Is Limited Under The Drug Addiction Treatment Act. ( 1)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
5. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

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

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