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Generated: December 15, 2018

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Details for New Drug Application (NDA): 017651

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NDA 017651 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Akorn, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Lilly, Luitpold, Mylan Labs Ltd, Organon Usa Inc, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Sagent Pharms, Sandoz, Shenzhen Techdow, Smith And Nephew, Solopak, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in sixty NDAs. It is available from thirteen suppliers. Additional details are available on the HEPARIN SODIUM profile page.

The generic ingredient in HEPARIN SODIUM is heparin sodium. There are seventy-seven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 017651
Tradename:HEPARIN SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:heparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017651
Suppliers and Packaging for NDA: 017651
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 017651 NDA Fresenius Kabi USA, LLC 63323-047 63323-047-10 25 VIAL in 1 TRAY (63323-047-10) > 10 mL in 1 VIAL

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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