Basic Information
topiramate
83008-011
Regulatory Information
83008-011
ANDA090162
C73584
June 22, 2023
USA
These highlights do not include all the information needed to use TOPIRAMATE TABLETS safely and effectively.See full prescribing information for TOPIRAMATE TABLETS TOPIRAMATE TABLETS, for oral useInitial U.S. Approval: 1996
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
831276758
Active Ingredients
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYETHYLENE GLYCOL 6000
Code: 30IQX730WE
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
POLYSORBATE 80
Code: 6OZP39ZG8H
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
TOPIRAMATE
Code: 0H73WJJ391