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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Baxter
Colorcon
McKinsey
Cipla
Deloitte
Novartis
Teva
Harvard Business School

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202202

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NDA 202202 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 202202
Tradename:WARFARIN SODIUM
Applicant:Amneal Pharms
Ingredient:warfarin sodium
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 202202
Mechanism of ActionVitamin K Inhibitors
Suppliers and Packaging for NDA: 202202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WARFARIN SODIUM warfarin sodium TABLET;ORAL 202202 ANDA Aidarex Pharmaceuticals LLC 53217-018 53217-018-90 90 TABLET in 1 BOTTLE, PLASTIC (53217-018-90)
WARFARIN SODIUM warfarin sodium TABLET;ORAL 202202 ANDA Aidarex Pharmaceuticals LLC 53217-018 53217-018-30 30 TABLET in 1 BOTTLE, PLASTIC (53217-018-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 4, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 4, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Chinese Patent Office
Fish and Richardson
Fuji
Colorcon
McKesson
Dow
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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