MedPath
FDA Approval

PREZISTA

August 23, 2010

HUMAN PRESCRIPTION DRUG LABEL

Darunavir(400 mg in 1 1)

Manufacturing Establishments (1)

State of Florida DOH Central Pharmacy

State of Florida DOH Central Pharmacy

829348114

Products (2)

PREZISTA

53808-0672

NDA021976

NDA (C73594)

ORAL

August 23, 2010

DarunavirActive
Code: 33O78XF0BWClass: ACTIBQuantity: 400 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

PREZISTA

53808-0773

NDA021976

NDA (C73594)

ORAL

August 23, 2010

DarunavirActive
Code: 33O78XF0BWClass: ACTIBQuantity: 600 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT
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