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Last Updated: November 4, 2024

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
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:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 10, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 10, 2020TE:ABRLD:No

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