MedPath
FDA Product

Zonisamide

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

Basic Information

Zonisamide

63187-897

Regulatory Information

63187-897

ANDA077634

C73584

April 1, 2022

USA

Zonisamide Capsules, for oral administration Rx only

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

Proficient Rx LP

079196022

Active Ingredients

ZONISAMIDE

Quantity: 100 mg in 1 1

Code: 459384H98V

Class Code: ACTIB

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Active Moieties

ZONISAMIDE

Code: 459384H98V

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