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FDA Approval

CRIXIVAN

CompanyRebel Distributors Corp (DUNS: 118802834)

Effective Date

September 24, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Indinavir(400 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp

Labeler

Rebel Distributors Corp

DUNS Number

118802834

Products (1)

CRIXIVAN

NDC Product Code

21695-366

Application Number

NDA020685

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

November 4, 2008

Ingredients

IndinavirActive

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

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

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