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FDA Drug information

Zonisamide

Read time: 1 mins
Marketing start date: 27 Apr 2024
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Summary of product characteristics


Effective Time

20231004

Version

7

Spl Product Data Elements

Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;31;25;mg Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;32;50;mg Zonisamide Zonisamide ZONISAMIDE ZONISAMIDE FD&C BLUE NO. 1 FD&C RED NO. 4 GELATIN HYDROGENATED COTTONSEED OIL CELLULOSE, MICROCRYSTALLINE SODIUM LAURYL SULFATE TITANIUM DIOXIDE PINK WHITE CAPSULE ZA;33;100;mg

Application Number

ANDA077625

Brand Name

Zonisamide

Generic Name

Zonisamide

Product Ndc

70771-1142

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1142-1 in bottle of 100 Capsules Zonisamide Capsules, 25 mg R x only 100 Capsules NDC 70771-1143-1 in bottle of 100 Capsules Zonisamide Capsules, 50 mg R x only 100 Capsules NDC 70771-1144-1 in bottle of 100 Capsules Zonisamide Capsules, 100 mg R x only 100 Capsules Zonisamide Capsules, 25 mg Zonisamide Capsules, 50 mg Zonisamide Capsules, 100 mg

Spl Medguide

Manufactured by: Cadila Healthcare Ltd. India

Drug section

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