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FDA Approval

Heparin sodium

CompanyMylan Institutional LLC (DUNS: 790384502)

Effective Date

October 23, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Heparin(20000 [USP'U] in 1 mL)

Products (1)

Heparin sodium

NDC Product Code

67457-373

Application Number

ANDA203852

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

February 11, 2019

Ingredients

Code: ZZ45AB24CAClass: ACTIMQuantity: 20000 [USP'U] in 1 mL

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

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