Last Updated: September 28, 2026

Details for New Drug Application (NDA): 209532

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NDA 209532 describes GEFITINIB, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Cipla, Natco, and Qilu Pharm Hainan, and is included in five NDAs. It is available from four suppliers. Additional details are available on the GEFITINIB profile page.

The generic ingredient in GEFITINIB is gefitinib. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the gefitinib profile page.

Summary for 209532

Tradename:	GEFITINIB
Applicant:	Apotex
Ingredient:	gefitinib
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Sep 23, 2022	TE:		RLD:	No

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