Application Nr Approved Date Route Status External Links
ANDA204945 2016-08-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Trospium Chloride Tablets Are A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder (oab) With Symptoms Of Urge Urinary Incontinence, Urgency, And Urinary Frequency. Trospium Chloride Tablets Are A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder (oab) With Symptoms Of Urge Urinary Incontinence, Urgency, And Urinary Frequency. (1)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Povidones POVIDONES Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Shellac SHELLAC Unresolved
11. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trospium Chloride TROSPIUM CHLORIDE ZINC100016084

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