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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 209728

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NDA 209728 describes REGORAFENIB, which is a drug marketed by Actavis Labs Fl and is included in one NDA. Additional details are available on the REGORAFENIB profile page.

The generic ingredient in REGORAFENIB is regorafenib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the regorafenib profile page.

Summary for 209728

Tradename:	REGORAFENIB
Applicant:	Actavis Labs Fl
Ingredient:	regorafenib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jan 13, 2025	TE:		RLD:	No

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