Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Medtronic
McKinsey
McKesson
UBS
Cerilliant
Baxter
Covington
Fish and Richardson

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040416

« Back to Dashboard

NDA 040416 describes JANTOVEN, which is a drug marketed by Usl Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the JANTOVEN profile page.

The generic ingredient in JANTOVEN 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 040416
Tradename:JANTOVEN
Applicant:Usl Pharma
Ingredient:warfarin sodium
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 040416
Mechanism of ActionVitamin K Inhibitors
Suppliers and Packaging for NDA: 040416
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JANTOVEN warfarin sodium TABLET;ORAL 040416 ANDA Upsher-Smith Laboratories, LLC 0832-1211 N 0832-1211-00
JANTOVEN warfarin sodium TABLET;ORAL 040416 ANDA Upsher-Smith Laboratories, LLC 0832-1211 N 0832-1211-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 2, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 2, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 2, 2003TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Baxter
Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Teva
Julphar
UBS
Queensland Health

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.