MedPath
FDA Approval

Heparin Sodium

December 12, 2022

HUMAN PRESCRIPTION DRUG LABEL

Heparin(5000 [USP'U] in 0.5 mL)

Manufacturing Establishments (1)

Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc.

946499746

Products (7)

Heparin Sodium

0641-6204

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 0.5 mL

Heparin Sodium

0641-6199

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL

Heparin Sodium

0641-2450

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL

Heparin Sodium

0641-0400

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL

Heparin Sodium

0641-2460

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL

Heparin Sodium

0641-0410

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL

Heparin Sodium

0641-0391

NDA017037

NDA (C73594)

INTRAVENOUS, SUBCUTANEOUS

December 12, 2022

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL
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