MedPath
FDA Approval

Morphine Sulfate

July 31, 2022

HUMAN PRESCRIPTION DRUG LABEL

Morphine(10 mg in 5 mL)

Products (2)

Morphine Sulfate

27808-084

ANDA203518

ANDA (C73584)

ORAL

July 31, 2022

EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 5 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1SClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT

Morphine Sulfate

27808-082

ANDA203518

ANDA (C73584)

ORAL

July 31, 2022

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
MorphineActive
Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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