MedPath
FDA Approval

Oxycodone and Acetaminophen

July 5, 2023

HUMAN PRESCRIPTION DRUG LABEL

Oxycodone(5 mg in 1 1)
Acetaminophen(325 mg in 1 1)

Registrants (1)

Direct_Rx

079254320

Manufacturing Establishments (1)

Direct_Rx

Direct_Rx

Direct_Rx

079254320

Products (1)

Oxycodone and Acetaminophen

72189-357

ANDA207419

ANDA (C73584)

ORAL

July 5, 2023

OxycodoneActive
Code: C1ENJ2TE6CClass: ACTIBQuantity: 5 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
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