Application Nr Approved Date Route Status External Links
ANDA091190 2015-03-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Darifenacin Hydrobromide Extended-Release Tablets Are A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency And Frequency. Darifenacin Hydrobromide Extended-Release Tablets Are A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency And Frequency. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
2. Hypromelloses HYPROMELLOSES 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. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Darifenacin Hydrobromide DARIFENACIN HYDROBROMIDE ZINC1996117

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