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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

Actavis Pharma, Inc.

DUNS: 119723554

Effective Date

November 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(90 mg in 1 1)

Products6

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

0228-3092

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 90 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Morphine sulfate

Product Details

NDC Product Code

0228-3093

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 120 mg in 1 1

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Morphine sulfate

Product Details

NDC Product Code

0228-3091

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

Morphine sulfate

Product Details

NDC Product Code

0228-3090

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

GELATINInactive

Code: 2G86QN327LClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Morphine sulfate

Product Details

NDC Product Code

0228-3117

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 75 mg in 1 1

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Morphine sulfate

Product Details

NDC Product Code

0228-3116

Application Number

ANDA079040

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 11, 2024

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 45 mg in 1 1

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

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