Treats asthma. ANDA 213163, held by Aurobindo Pharma. Zafirlukast.
As of Nov 15, 2026, ANDA 213163 (Zafirlukast), held by Aurobindo Pharma, was first approved by FDA on Nov 27, 2023, with 0 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 27, 2023 | 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
