MedPath
FDA Approval

Morphine Sulfate

September 6, 2023

HUMAN PRESCRIPTION DRUG LABEL

Morphine(30 mg in 1 1)

Manufacturing Establishments (1)

West-Ward Columbus Inc.

Hikma Pharmaceuticals USA Inc.

058839929

Products (2)

Morphine Sulfate

0054-0236

NDA022207

NDA (C73594)

ORAL

September 1, 2018

MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT

Morphine Sulfate

0054-0235

NDA022207

NDA (C73594)

ORAL

September 1, 2018

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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