MedPath
FDA Approval

AVINZA

September 22, 2011

HUMAN PRESCRIPTION DRUG LABEL

Morphine(60 mg in 1 1)

Manufacturing Establishments (1)

STAT RX USA LLC

STAT RX USA LLC

786036330

Products (3)

AVINZA

16590-593

NDA021260

NDA (C73594)

ORAL

September 22, 2011

POVIDONEInactive
Code: FZ989GH94EClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIMQuantity: 60 mg in 1 1
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT

AVINZA

16590-594

NDA021260

NDA (C73594)

ORAL

September 22, 2011

FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIMQuantity: 30 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT

AVINZA

16590-597

NDA021260

NDA (C73594)

ORAL

September 22, 2011

MorphineActive
Code: X3P646A2J0Class: ACTIMQuantity: 90 mg in 1 1
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FUMARIC ACIDInactive
Code: 88XHZ13131Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
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