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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019953


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NDA 019953 describes HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, and Hospira, and is included in four NDAs. It is available from four suppliers. Additional details are available on the HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 019953
Tradename:HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:B Braun
Ingredient:heparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019953
Suppliers and Packaging for NDA: 019953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019953 NDA B. Braun Medical Inc. 0264-9872 0264-9872-00 12 CONTAINER in 1 CASE (0264-9872-00) / 1000 mL in 1 CONTAINER
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER heparin sodium INJECTABLE;INJECTION 019953 NDA B. Braun Medical Inc. 0264-9872 0264-9872-10 24 CONTAINER in 1 CASE (0264-9872-10) / 500 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 UNITS/100ML
Approval Date:Jul 20, 1992TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 UNITS/100ML
Approval Date:Dec 15, 2023TE:RLD:Yes

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