Treats asthma. ANDA 90372, held by Dr Reddys Labs Ltd. Zafirlukast.
As of Nov 15, 2026, ANDA 90372 (Zafirlukast), held by Dr Reddys Labs Ltd, was first approved by FDA on Nov 18, 2010, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zafirlukast tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2010 | Original application | Approved |
| Zafirlukast10MG · tablet;oral | Zafirlukast | Rx |
| Zafirlukast20MG · tablet;oral | Zafirlukast | Rx |
| Mar 7, 2014 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 27, 2011 | Supplement 1Labeling | Approved | None posted |
| Nov 18, 2010 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
