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Generated: January 24, 2019

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Details for New Drug Application (NDA): 019953

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NDA 019953 describes HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 019953
Tradename:HEPARIN SODIUM 1,000 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 0264-9872-10 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

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