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FDA Drug information

Divalproex sodium

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20230921

Version

8

Spl Product Data Elements

divalproex sodium divalproex sodium DIVALPROEX SODIUM VALPROIC ACID ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES ISOPROPYL ALCOHOL METHACRYLIC ACID POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER BLUE WHITE CAPSULE ZA66;125mg

Application Number

ANDA078919

Brand Name

Divalproex sodium

Generic Name

divalproex sodium

Product Ndc

65841-639

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-639-01 in bottle of 100 Capsules Divalproex sodium delayed-release capsules, USP (sprinkle) Rx only 100 capsules Divalproex Sodium Capsules Sprinkle, 125 mg

Spl Medguide

SPL MEDGUIDE

Drug section

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