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FDA Approval

CRIXIVAN

CompanySTAT Rx USA LLC (DUNS: 786036330)

Effective Date

June 14, 2012

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Indinavir(400 mg in 1 1)

Registrants (1)

PSS World Medical Inc.

DUNS Number

101822682

Manufacturing Establishments (1)

STAT Rx USA LLC

Labeler

STAT Rx USA LLC

Registrant

PSS World Medical Inc.

DUNS Number

786036330

Products (1)

CRIXIVAN

NDC Product Code

16590-064

Application Number

NDA020685

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 14, 2012

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

IndinavirActive

Code: 771H53976QClass: ACTIMQuantity: 400 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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