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FDA Approval

Morphine Sulfate

CompanySpecGx LLC (DUNS: 080679498)

Effective Date

January 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(20 mg in 1 mL)

Manufacturing Establishments (1)

Labeler

SpecGx LLC

DUNS Number

163205300

Products (1)

Morphine Sulfate

NDC Product Code

0406-8003

Application Number

ANDA202348

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 30, 2023

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 mL

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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