MedPath
FDA Product

TOPIRAMATE

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

Basic Information

TOPIRAMATE

59651-452

Regulatory Information

59651-452

ANDA215449

C73584

February 19, 2024

USA

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

Human Prescription Drug Label

2

Company Information

650082092

Active Ingredients

TOPIRAMATE

Quantity: 15 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

CELLULOSE ACETATE

Code: 3J2P07GVB6

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

TOPIRAMATE

Code: 0H73WJJ391

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