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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 040416


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NDA 040416 describes JANTOVEN, which is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from one supplier. 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. Twenty-two suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.
Summary for 040416
Tradename:JANTOVEN
Applicant:Upsher Smith Labs
Ingredient:warfarin sodium
Patents:0
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 0832-1211-00 100 TABLET in 1 BOTTLE (0832-1211-00)
JANTOVEN warfarin sodium TABLET;ORAL 040416 ANDA Upsher-Smith Laboratories, LLC 0832-1211 0832-1211-01 100 BLISTER PACK in 1 CARTON (0832-1211-01) > 1 TABLET in 1 BLISTER PACK (0832-1211-89)

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

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