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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 088100


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NDA 088100 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 088100
Tradename:HEPARIN SODIUM
Applicant:Hospira
Ingredient:heparin sodium
Patents:0
Pharmacology for NDA: 088100
Suppliers and Packaging for NDA: 088100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 088100 ANDA Hospira, Inc. 0409-1402 0409-1402-12 50 CARTRIDGE in 1 BOX (0409-1402-12) / 1 mL in 1 CARTRIDGE (0409-1402-27)
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 088100 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1460 51662-1460-1 1 mL in 1 CARTRIDGE (51662-1460-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML
Approval Date:Apr 28, 1983TE:RLD:No

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