ANDA 202477, held by Apotex Inc. Rizatriptan Benzoate.
As of Nov 14, 2026, ANDA 202477 (Rizatriptan Benzoate), held by Apotex Inc, was first approved by FDA on Jul 1, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2013 | Original application | Approved | None posted |
| Rizatriptan BenzoateEQ 5MG BASE · tablet, orally disintegrating;oral | Rizatriptan Benzoate | Discontinued |
| Rizatriptan BenzoateEQ 10MG BASE · tablet, orally disintegrating;oral | Rizatriptan Benzoate | Discontinued |
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