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Generated: April 20, 2018

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, Taro Pharm, Usl Pharma, Watson Labs, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from thirty-three 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:WARFARIN SODIUM
Applicant:Taro Pharm
Ingredient:warfarin sodium
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 Aidarex Pharmaceuticals LLC 33261-355 N 33261-355-30
WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301 ANDA Aidarex Pharmaceuticals LLC 33261-355 N 33261-355-00

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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