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FDA Drug information

Topiramate

Read time: 1 mins
Marketing start date: 19 May 2024
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Summary of product characteristics


Effective Time

20221031

Version

9

Spl Product Data Elements

topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WHITE CAPSULE ZA63;15mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WHITE CAPSULE ZA64;25mg

Application Number

ANDA078877

Brand Name

Topiramate

Generic Name

topiramate

Product Ndc

65841-651

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only Topiramate Capsules (Sprinkle), 15 mg Topiramate Capsules (Sprinkle), 25 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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