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Cipla
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Harvard Business School
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Dow
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McKinsey
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Argus Health
Express Scripts

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040145

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NDA 040145 describes WARFARIN SODIUM, which is a drug marketed by Amneal Pharms, Barr, Invagen Pharms, Ipca Labs Ltd, Mylan, Pliva, Taro Pharm, Usl Pharma, Watson Labs, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from thirty-two suppliers. Additional details are available on the WARFARIN SODIUM profile page.

The generic ingredient in WARFARIN SODIUM is warfarin sodium. There are twenty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.
Summary for 040145
Tradename:WARFARIN SODIUM
Applicant:Barr
Ingredient:warfarin sodium
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 040145
Mechanism of ActionVitamin K Inhibitors
Suppliers and Packaging for NDA: 040145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WARFARIN SODIUM warfarin sodium TABLET;ORAL 040145 ANDA Teva Pharmaceuticals USA, Inc. 0555-0834 N 0555-0834-02
WARFARIN SODIUM warfarin sodium TABLET;ORAL 040145 ANDA Teva Pharmaceuticals USA, Inc. 0555-0835 N 0555-0835-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 26, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 26, 1997TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 26, 1997TE:ABRLD:No

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