MedPath
FDA Product

TOPIRAMATE

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

Basic Information

TOPIRAMATE

31722-182

Regulatory Information

31722-182

ANDA215414

C73584

June 16, 2023

USA

These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively. See full prescribing information for TOPIRAMATE TABLETS. TOPIRAMATE tablets, for oral useInitial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

826774775

Active Ingredients

TOPIRAMATE

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A

Code: H8AV0SQX4D

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

Active Moieties

TOPIRAMATE

Code: 0H73WJJ391

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