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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

Par Pharmaceutical Inc.

DUNS: 092733690

Effective Date

February 19, 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Morphine(100 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Par Pharmaceutical Inc.

DUNS Number

092733690

Manufacturing Establishments4

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

SGS Life Science Services

Labeler

Par Pharmaceutical Inc.

Registrant

Par Pharmaceutical Inc.

DUNS Number

062491980

Whitehouse Analytical Laboratories

Labeler

Par Pharmaceutical Inc.

Registrant

Par Pharmaceutical Inc.

DUNS Number

138628008

Watson Laboratories, Inc.

Labeler

Par Pharmaceutical Inc.

Registrant

Par Pharmaceutical Inc.

DUNS Number

840054118

Watson Laboratories, Inc. - Florida

Labeler

Par Pharmaceutical Inc.

Registrant

Par Pharmaceutical Inc.

DUNS Number

014759176

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

49884-670

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

49884-668

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

49884-667

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 1

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

49884-665

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 1

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

49884-666

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

Morphine Sulfate

Product Details

NDC Product Code

49884-669

Application Number

ANDA200812

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 19, 2015

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

Code: X3P646A2J0Class: ACTIBQuantity: 80 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

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