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FDA Approval

Morphine Sulfate

CompanyATLANTIC BIOLOGICALS CORP. (DUNS: 047437707)

Effective Date

January 20, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(10 mg in 5 mL)

Manufacturing Establishments (1)

ATLANTIC BIOLOGICALS CORP.

Labeler

ATLANTIC BIOLOGICALS CORP.

DUNS Number

047437707

Products (1)

Morphine Sulfate

NDC Product Code

17856-1170

Application Number

ANDA205509

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 18, 2021

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 5 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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