MedPath
FDA Approval

Oxycodone Hydrochloride

February 8, 2022

HUMAN PRESCRIPTION DRUG LABEL

Oxycodone(15 mg in 1 1)

Products (2)

Oxycodone Hydrochloride

0904-7180

ANDA203638

ANDA (C73584)

ORAL

February 8, 2022

STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
OxycodoneActive
Code: C1ENJ2TE6CClass: ACTIBQuantity: 15 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT

Oxycodone Hydrochloride

0904-6966

ANDA203638

ANDA (C73584)

ORAL

February 8, 2022

OxycodoneActive
Code: C1ENJ2TE6CClass: ACTIBQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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