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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 017651


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NDA 017651 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Aspen Global Inc, B Braun Medical Inc, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Mylan Labs Ltd, Nanjing King-friend, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Sagent Pharms, Sandoz, Shenzhen Techdow, Smith And Nephew, Solopak, Watson Labs Inc, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in sixty-nine NDAs. It is available from twenty 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. Twenty-two 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
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 (63323-047-01)

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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