Details for New Drug Application (NDA): 211826

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NDA 211826 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 five suppliers. Additional details are available on the GEFITINIB profile page.

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

Summary for 211826

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	May 16, 2025	TE:	AB	RLD:	No

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