Application Nr Approved Date Route Status External Links
ANDA202446 2014-06-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage For The Relief Of Symptoms Of Depression. Endogenous Depression Is More Likely To Be Alleviated Than Are Other Depressive States.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Lecithin LECITHIN Unresolved
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. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE ZINC968257

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