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
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