MedPath
FDA Approval

COMBIVIR

September 24, 2010

HUMAN PRESCRIPTION DRUG LABEL

Lamivudine(150 mg in 1 1)
Zidovudine(300 mg in 1 1)

Manufacturing Establishments (1)

Rebel Distributors Corp

Rebel Distributors Corp

118802834

Products (1)

COMBIVIR

21695-846

NDA020857

NDA (C73594)

ORAL

May 12, 2009

Code: 2T8Q726O95Class: ACTIBQuantity: 150 mg in 1 1
Code: 4B9XT59T7SClass: ACTIBQuantity: 300 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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