MedPath
FDA Approval

Heparin Sodium

November 22, 2021

HUMAN PRESCRIPTION DRUG LABEL

Heparin(1000 [USP'U] in 1 mL)

Products (7)

Heparin Sodium

71288-421

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT

Heparin Sodium

71288-420

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL
waterInactive
Code: 059QF0KO0RClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT

Heparin Sodium

71288-422

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT

Heparin Sodium

71288-425

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT
waterInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

71288-424

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT

Heparin Sodium

71288-419

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 0.01 mL in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT

Heparin Sodium

71288-423

ANDA211007

ANDA (C73584)

INTRAVENOUS, SUBCUTANEOUS

November 22, 2021

HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACTQuantity: 10.42 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT
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