KADIAN

Manufacturing Establishments (1)

STAT RX USA LLC

Labeler

STAT RX USA LLC

DUNS Number

786036330

Products (7)

NDC Product Code

16590-885

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 200 mg in 1 1

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

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

Code: 74G4R6TH13Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

KADIAN

NDC Product Code

16590-740

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 100 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

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

Code: 74G4R6TH13Class: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

KADIAN

NDC Product Code

16590-598

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 60 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

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

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

KADIAN

NDC Product Code

16590-606

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 50 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

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

Code: 74G4R6TH13Class: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

KADIAN

NDC Product Code

16590-778

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 80 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

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

Code: 74G4R6TH13Class: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

KADIAN

NDC Product Code

16590-660

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 30 mg in 1 1

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

Code: 74G4R6TH13Class: IACT

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

KADIAN

NDC Product Code

16590-697

Application Number

NDA020616

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

June 15, 2011

Ingredients

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

MorphineActive

Code: X3P646A2J0Class: ACTIBQuantity: 20 mg in 1 1

DIETHYL PHTHALATEInactive

Code: UF064M00AFClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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

Code: 74G4R6TH13Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

AI-Powered Research

Premium Access

KADIAN

Manufacturing Establishments (1)

Products (7)

KADIAN

KADIAN

KADIAN

KADIAN

KADIAN

KADIAN

KADIAN