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FDA Approval

ZOLPIDEM TARTRATE

CompanyMedsource Pharmaceuticals (DUNS: 833685915)

Effective Date

July 21, 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Zolpidem(10 mg in 1 1)

Registrants (1)

Medsource Pharmaceuticals

DUNS Number

833685915

Manufacturing Establishments (1)

Medsource Pharmaceuticals

Labeler

Medsource Pharmaceuticals

Registrant

Medsource Pharmaceuticals

DUNS Number

833685915

Products (1)

ZOLPIDEM TARTRATE

NDC Product Code

45865-413

Application Number

ANDA077903

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 21, 2015

Ingredients

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Code: WY6W63843KClass: ACTIBQuantity: 10 mg in 1 1

Drug Labeling Information

RECENT MAJOR CHANGES SECTION

RECENT MAJOR CHANGES

Warnings and Precautions, Severe Injuries (5.8) 10/2014

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