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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212475

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NDA 212475 describes ZAFIRLUKAST, which is a drug marketed by Annora Pharma, Aurobindo Pharma, Dr Reddys Labs Ltd, and Rising Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ZAFIRLUKAST profile page.

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

Summary for 212475

Tradename:	ZAFIRLUKAST
Applicant:	Annora Pharma
Ingredient:	zafirlukast
Patents:	0

Pharmacology for NDA: 212475

Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Suppliers and Packaging for NDA: 212475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZAFIRLUKAST	zafirlukast	TABLET;ORAL	212475	ANDA	Camber Pharmaceuticals, Inc.	31722-007	31722-007-01	10 BLISTER PACK in 1 CARTON (31722-007-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ZAFIRLUKAST	zafirlukast	TABLET;ORAL	212475	ANDA	Camber Pharmaceuticals, Inc.	31722-007	31722-007-05	500 TABLET, FILM COATED in 1 BOTTLE (31722-007-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 10, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 10, 2020	TE:	AB	RLD:	No

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