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FDA Approval

ZOLPIDEM TARTRATE

CompanyH.J. Harkins Company, Inc. (DUNS: 147681894)

Effective Date

August 18, 2011

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Zolpidem(10 mg in 1 1)

Manufacturing Establishments (1)

Torrent Pharmaceuticals Limited

Labeler

H.J. Harkins Company, Inc.

DUNS Number

916488547

Products (1)

ZOLPIDEM TARTRATE

NDC Product Code

52959-880

Application Number

ANDA077903

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 19, 2011

Ingredients

Code: WY6W63843KClass: ACTIBQuantity: 10 mg in 1 1

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