Zafirlukast

Product NDC
59651-292
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zafirlukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213163
Marketing category
ANDA
Substance
ZAFIRLUKAST
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
59651-292-6060 TABLET, FILM COATED in 1 BOTTLE (59651-292-60) 2023-11-27NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Zafirlukast Tablets Rx onlyAurobindo Pharma Limited | APL HEALTHCARE LIMITED2023-12-01Human Prescription Drug Label1