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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 200104

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NDA 200104 describes WARFARIN SODIUM, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Ipca Labs Ltd, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-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. Twenty-four suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

Summary for 200104

Tradename:	WARFARIN SODIUM
Applicant:	Ipca Labs Ltd
Ingredient:	warfarin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jun 27, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jun 27, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jun 27, 2013	TE:	AB	RLD:	No

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