MedPath
FDA Product

Topiramate

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

Basic Information

Topiramate

27241-228

Regulatory Information

27241-228

ANDA215663

C73584

July 19, 2023

USA

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

Human Prescription Drug Label

5

Company Information

557554156

Active Ingredients

TOPIRAMATE

Quantity: 50 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

SUCROSE

Code: C151H8M554

Class Code: IACT

ETHYLCELLULOSE, UNSPECIFIED

Code: 7Z8S9VYZ4B

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

MEDIUM-CHAIN TRIGLYCERIDES

Code: C9H2L21V7U

Class Code: IACT

OLEIC ACID

Code: 2UMI9U37CP

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

SHELLAC

Code: MB5IUD6JUA

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

LECITHIN, SOYBEAN

Code: 1DI56QDM62

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Active Moieties

TOPIRAMATE

Code: 0H73WJJ391

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