MedPath
FDA Approval

ZYDONE

July 13, 2010

HUMAN PRESCRIPTION DRUG LABEL

Acetaminophen(400 mg in 1 1)
Hydrocodone(7.5 mg in 1 1)

Manufacturing Establishments (1)

STAT RX USA LLC

STAT RX USA LLC

786036330

Products (1)

ZYDONE

16590-350

ANDA040288

ANDA (C73584)

ORAL

July 13, 2010

POVIDONEInactive
Code: FZ989GH94EClass: IACT
Code: 362O9ITL9DClass: ACTIBQuantity: 400 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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