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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 211650

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NDA 211650 describes AXITINIB, which is a drug marketed by Apotex and is included in one NDA. Additional details are available on the AXITINIB profile page.

The generic ingredient in AXITINIB is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

Summary for 211650

Tradename:	AXITINIB
Applicant:	Apotex
Ingredient:	axitinib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 30, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 30, 2025	TE:	AB	RLD:	No

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