MedPath
FDA Approval

OXYCODONE AND ACETAMINOPHEN

November 28, 2023

HUMAN PRESCRIPTION DRUG LABEL

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

Manufacturing Establishments (1)

RedPharm Drug, Inc

Redpharm Drug, Inc

828374897

Products (1)

OXYCODONE AND ACETAMINOPHEN

67296-1855

ANDA207510

ANDA (C73584)

ORAL

November 28, 2023

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
OxycodoneActive
Code: C1ENJ2TE6CClass: ACTIBQuantity: 5 mg in 1 1
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