Treprostinil

Products (5)

DILUENT

NDC Product Code

0781-6021

Application Number

ANDA203649

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS, INTRAVENOUS

Effective Date

October 3, 2018

Ingredients

WaterActive

Code: 059QF0KO0RClass: ACTIBQuantity: 1 mL in 1 mL

GLYCINEInactive

Code: TE7660XO1CClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

NDC Product Code

0781-3420

Application Number

ANDA203649

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS, INTRAVENOUS

Effective Date

October 3, 2018

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

TreprostinilActive

Code: RUM6K67ESGClass: ACTIBQuantity: 20 mg in 20 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

METACRESOLInactive

Code: GGO4Y809LOClass: IACT

Treprostinil

NDC Product Code

0781-3425

Application Number

ANDA203649

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS, INTRAVENOUS

Effective Date

October 3, 2018

Ingredients

TreprostinilActive

Code: RUM6K67ESGClass: ACTIBQuantity: 50 mg in 20 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

METACRESOLInactive

Code: GGO4Y809LOClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

Treprostinil

NDC Product Code

0781-3430

Application Number

ANDA203649

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS, INTRAVENOUS

Effective Date

October 3, 2018

Ingredients

METACRESOLInactive

Code: GGO4Y809LOClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

TreprostinilActive

Code: RUM6K67ESGClass: ACTIBQuantity: 200 mg in 20 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Treprostinil

NDC Product Code

0781-3427

Application Number

ANDA203649

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS, INTRAVENOUS

Effective Date

October 3, 2018

Ingredients

TreprostinilActive

Code: RUM6K67ESGClass: ACTIBQuantity: 100 mg in 20 mL

METACRESOLInactive

Code: GGO4Y809LOClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

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Treprostinil

Products (5)

DILUENT

Treprostinil

Treprostinil

Treprostinil

Treprostinil