Treats migraine with or without aura. ANDA 203269, held by Alkem Labs Ltd. Rizatriptan Benzoate.
As of Nov 14, 2026, ANDA 203269 (Rizatriptan Benzoate), held by Alkem Labs Ltd, was first approved by FDA on Feb 18, 2016, with 3 approved supplements and 0 published complete response letters.
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2016 | Original application | Approved | None posted |
| Rizatriptan BenzoateEQ 5MG BASE · tablet;oral | Rizatriptan Benzoate | Rx |
| Rizatriptan BenzoateEQ 10MG BASE · tablet;oral | Rizatriptan Benzoate | Rx |
| Jan 22, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 22, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 19, 2016 | Supplement 1Manufacturing | Approved | None posted |
| Feb 18, 2016 | Original application | Approved | None posted |
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
