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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018916

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NDA 018916 describes HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Hospira and B Braun and is included in two NDAs. It is available from one supplier. Additional details are available on the HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% is heparin sodium. There are seventy-seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 018916
Tradename:HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
Applicant:Hospira
Ingredient:heparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018916
Ingredient-typeHeparin
Suppliers and Packaging for NDA: 018916
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 018916 NDA Hospira, Inc. 0409-7620 N 0409-7620-03
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% heparin sodium INJECTABLE;INJECTION 018916 NDA Hospira, Inc. 0409-7620 N 0409-7620-03

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1,000 UNITS/100ML
Approval Date:Jan 31, 1984TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/100ML
Approval Date:Jan 31, 1984TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/100ML
Approval Date:Jan 31, 1984TE:RLD:No

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