Treats migraine with or without aura. ANDA 207835, held by Unichem. Rizatriptan Benzoate.
As of Nov 14, 2026, ANDA 207835 (Rizatriptan Benzoate), held by Unichem, was first approved by FDA on Mar 7, 2017, with 1 approved supplement and 0 published complete response letters.
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age Limitations of Use Use only after clear diagnosis of migraine has been established Not indicated for the prophylactic therapy of migraine Not indicated for the treatment of cluster headache
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2017 | 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 |
| Feb 9, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 7, 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
