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Serving leading biopharmaceutical companies globally:

Baxter
Chubb
Moodys
US Army
Medtronic
Argus Health
Covington
Novartis
Johnson and Johnson
Cerilliant

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040301

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NDA 040301 describes WARFARIN SODIUM, which is a drug marketed by Amneal Pharms, Barr, Invagen Pharms, Ipca Labs Ltd, Mylan, Pliva, Sandoz, Taro Pharm, Usl Pharma, Watson Labs, 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 040301

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 040301

Mechanism of ActionVitamin K Inhibitors

Suppliers and Packaging for NDA: 040301

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301 ANDA STAT Rx USA LLC 16590-340 16590-340-40 40 TABLET in 1 BOTTLE (16590-340-40)
WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301 ANDA STAT Rx USA LLC 16590-340 16590-340-30 30 TABLET in 1 BOTTLE (16590-340-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 15, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 15, 1999TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 15, 1999TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Fish and Richardson
Dow
Federal Trade Commission
Julphar
Teva
Argus Health
Fuji
Moodys
AstraZeneca

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