Treats migraine with or without aura. ANDA 207836, held by Unichem. Rizatriptan Benzoate.
As of Nov 15, 2026, ANDA 207836 (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;oral | Rizatriptan Benzoate | Discontinued |
| Rizatriptan BenzoateEQ 10MG BASE · tablet;oral | Rizatriptan Benzoate | Discontinued |
| Nov 29, 2019 | Supplement 1Labeling · 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
