Details for New Drug Application (NDA): 040416

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-five 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

Pharmacology for NDA: 040416

Mechanism of Action

Vitamin 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:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 2, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 2, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 2, 2003	TE:	AB	RLD:	No

Complete Access Available with Subscription