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FDA Approval

Morphine Sulfate

CompanyQuality Care Products LLC (DUNS: 831276758)

Effective Date

July 25, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(15 mg in 1 1)

Manufacturing Establishments (1)

Quality Care Products LLC

Labeler

Quality Care Products LLC

DUNS Number

831276758

Products (1)

Morphine Sulfate

NDC Product Code

49999-848

Application Number

NDA022207

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 6, 2020

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 15 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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