MedPath
FDA Product

Torsemide

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

Basic Information

Torsemide

62135-820

Regulatory Information

62135-820

ANDA076894

C73584

February 1, 2024

USA

Torsemide Tablets, USP These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Chartwell RX, LLC

079394054

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE, UNSPECIFIED

Code: 2S7830E561

Class Code: IACT

TORSEMIDE

Quantity: 20 mg in 1 1

Code: W31X2H97FB

Class Code: ACTIB

Active Moieties

TORSEMIDE

Code: W31X2H97FB

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