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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204928

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NDA 204928 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 204928

Tradename:	ZAFIRLUKAST
Applicant:	Rising Pharms
Ingredient:	zafirlukast
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 25, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 25, 2022	TE:	AB	RLD:	No

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