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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091682

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NDA 091682 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Akorn, Chamberlin Parenterl, Dell Labs, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hospira Inc, Lilly, Luitpold, 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 fifty-eight NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for 091682

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 091682

Ingredient-typeHeparin

Suppliers and Packaging for NDA: 091682

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPARIN SODIUM heparin sodium INJECTABLE;INJECTION 091682 ANDA Sandoz Inc 0781-3327 0781-3327-95 10 VIAL, MULTI-DOSE in 1 TRAY (0781-3327-95) > 1 mL in 1 VIAL, MULTI-DOSE (0781-3327-71)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1,000 UNITS/ML
Approval Date:Jun 8, 2011TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000 UNITS/ML
Approval Date:Jun 8, 2011TE:APRLD:No


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