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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090808

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NDA 090808 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 090808
Tradename:HEPARIN SODIUM
Applicant:Sagent Pharms
Ingredient:heparin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090808
Ingredient-typeHeparin
Suppliers and Packaging for NDA: 090808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 090808 ANDA Sagent Pharmaceticals 25021-400 N 25021-400-66
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 090808 ANDA Sagent Pharmaceticals 25021-400 N 25021-400-67

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1,000 UNITS/ML
Approval Date:Jun 30, 2010TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML
Approval Date:Jun 30, 2010TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10,000 UNITS/ML
Approval Date:Jun 30, 2010TE:APRLD:No

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