MedPath
FDA Product

Trospium Chloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Trospium Chloride

71610-812

Regulatory Information

71610-812

ANDA204945

C73584

April 2, 2024

USA

These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

128385585

Active Ingredients

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TROSPIUM CHLORIDE

Quantity: 20 mg in 1 1

Code: 1E6682427E

Class Code: ACTIB

SUCROSE

Code: C151H8M554

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

TROSPIUM

Code: T4Y8ORK057

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