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FDA Drug information

Topiramate

Read time: 1 mins
Marketing start date: 22 Nov 2024
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Summary of product characteristics


Effective Time

20230927

Version

8

Spl Product Data Elements

topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;16 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;15 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;14 topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE ANHYDROUS LACTOSE WHITE TO OFF-WHITE ROUND ZD;13

Application Number

ANDA078235

Brand Name

Topiramate

Generic Name

topiramate

Product Ndc

65841-650

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-647-14 in bottle of 60 tablets Topiramate Tablets USP, 25 mg 60 tablets Rx only NDC 65841-648-14 in bottle of 60 tablets Topiramate Tablets USP, 50 mg 60 tablets Rx only NDC 65841-649-14 in bottle of 60 tablets Topiramate Tablets USP, 100 mg 60 tablets Rx only NDC 65841-650-14 in bottle of 60 tablets Topiramate Tablets USP, 200 mg 60 tablets Rx only Topiramate Tablets Topiramate Tablets Topiramate Tablets Topiramate Tablets

Drug section

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