DIANEAL PD-2 with Dextrose

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 4.25 g in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 25.7 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

DIANEAL PD-2 with Dextrose

NDC Product Code

0941-0415

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 4.25 g in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 25.7 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

DIANEAL Low Calcium with Dextrose

NDC Product Code

0941-0424

Application Number

NDA020183

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: M4I0D6VV5MClass: ACTIBQuantity: 18.3 mg in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

DIANEAL Low Calcium with Dextrose

NDC Product Code

0941-0433

Application Number

NDA020183

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 4.25 g in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 18.3 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

DIANEAL PD-2 with Dextrose

NDC Product Code

0941-0413

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

Code: M4I0D6VV5MClass: ACTIBQuantity: 25.7 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 2.5 g in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

DIANEAL PD-2 with Dextrose

NDC Product Code

0941-0411

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 25.7 mg in 100 mL

DIANEAL PD-2 with Dextrose

NDC Product Code

0941-0426

Application Number

NDA020163

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: M4I0D6VV5MClass: ACTIBQuantity: 25.7 mg in 100 mL

DIANEAL Low Calcium with Dextrose

NDC Product Code

0941-0487

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 2.5 g in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

DIANEAL Low Calcium with Dextrose

NDC Product Code

0941-0457

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 18.3 mg in 100 mL

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 2.5 g in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

DIANEAL Low Calcium with Dextrose

NDC Product Code

0941-0484

Application Number

NDA017512

Marketing Category

NDA (C73594)

Route of Administration

INTRAPERITONEAL

Effective Date

November 21, 2019

Ingredients

GlucoseActive

Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL

Lactic acidActive

Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL