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Details for New Drug Application (NDA): 017540

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NDA 017540 describes HEPARIN SODIUM, which is a drug marketed by Hospira, Sandoz, Eurohlth Intl Sarl, Solopak, Watson Labs Inc, Sagent Pharms, Lilly, Fresenius Kabi Usa, Chamberlin Parenterl, Abraxis Pharm, Shenzhen Techdow, West-ward Pharms Int, Smith And Nephew, Dell Labs, Parke Davis, Luitpold, Organon Usa Inc, Watson Labs, Pfizer, Pharmacia And Upjohn, Hospira Inc, Pharm Spec, Akorn, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in fifty-seven NDAs. It is available from eleven suppliers. Additional details are available on the HEPARIN SODIUM profile page.

The generic ingredient in HEPARIN SODIUM is heparin sodium. There are seventy-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for NDA: 017540

Tradename:
HEPARIN SODIUM
Applicant:
Dell Labs
Ingredient:
heparin sodium
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

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


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