Treats asthma. ANDA 212475, held by Annora Pharma. Zafirlukast.
As of Nov 15, 2026, ANDA 212475 (Zafirlukast), held by Annora Pharma, was first approved by FDA on Sep 10, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Zafirlukast is indicated for the prophylaxis and chronic treatment of asthma in adults and children 5 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2020 | Original application | Approved | None posted |
| Zafirlukast10MG · tablet;oral | Zafirlukast | Rx |
| Zafirlukast20MG · tablet;oral | Zafirlukast | Rx |
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
