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FDA Approval

Morphine Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Winder Laboratories LLC

DUNS: 965195170

Effective Date

February 28, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(20 mg in 5 mL)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Morphine Sulfate

Product Details

NDC Product Code

75826-130

Application Number

ANDA211454

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2022

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

NITROGENInactive

Code: N762921K75Class: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 5 mL

Morphine Sulfate

Product Details

NDC Product Code

75826-129

Application Number

ANDA211454

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2022

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

NITROGENInactive

Code: N762921K75Class: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 10 mg in 5 mL

Morphine Sulfate

Product Details

NDC Product Code

75826-131

Application Number

ANDA211454

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2022

Ingredients

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

NITROGENInactive

Code: N762921K75Class: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0LClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 5 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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