Treats migraine with or without aura. ANDA 91441, held by Orbion Pharms. Naratriptan Hydrochloride.
As of Nov 15, 2026, ANDA 91441 (Naratriptan), held by Orbion Pharms, was first approved by FDA on Apr 30, 2012, with 3 approved supplements and 0 published complete response letters.
Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks. Naratriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of naratriptan tablets have not been established for cluster headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2012 | Original application | Approved | None posted |
| NaratriptanEQ 1MG BASE · tablet;oral | Naratriptan Hydrochloride | Rx |
| NaratriptanEQ 2.5MG BASE · tablet;oral | Naratriptan Hydrochloride | Rx |
| Oct 27, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 16, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 10, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 30, 2012 | 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
