Treats migraine with or without aura. ANDA 204722, held by Panacea. Rizatriptan Benzoate.
As of Nov 14, 2026, ANDA 204722 (Rizatriptan Benzoate), held by Panacea, was first approved by FDA on Jan 11, 2017, with 1 approved supplement and 0 published complete response letters.
Rizatriptan Benzoate Orally Disintegrating 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 orally disintegrating 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 orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2017 | Original application | Approved | None posted |
| Rizatriptan BenzoateEQ 5MG BASE · tablet, orally disintegrating;oral | Rizatriptan Benzoate | Rx |
| Rizatriptan BenzoateEQ 10MG BASE · tablet, orally disintegrating;oral | Rizatriptan Benzoate | Rx |
| Mar 26, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 11, 2017 | 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
