Application Nr Approved Date Route Status External Links
ANDA091149 2014-09-08 Sublingual RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Buprenorphine And Naloxone Sublingual Tablets Are Indicated For The Maintenance Treatment Of Opioid Dependence And 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 Healthcare Providers 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 And Naloxone Sublingual Tablets Are Indicated For The Maintenance Treatment Of Opioid Dependence. Prescription Use Of This Product Is Limited Under The Drug Addiction Treatment Act. (1)

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
6. Povidones POVIDONES Unresolved
7. Acetone ACETONE Molecular SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 2 Total)

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