MedPath
FDA Product

Topiramate

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

Basic Information

Topiramate

10370-368

Regulatory Information

10370-368

ANDA205976

C73584

March 9, 2023

USA

These highlights do not include all the information needed to use  safely and effectively. See full prescribing information for CAPSULES. for oral use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

092733690

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

ETHYLCELLULOSE (10 MPA.S)

Code: 3DYK7UYZ62

Class Code: IACT

TOPIRAMATE

Quantity: 200 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Active Moieties

TOPIRAMATE

Code: 0H73WJJ391

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