Treats migraine with or without aura. ANDA 214209, held by Cipla. Sumatriptan.
As of Nov 13, 2026, ANDA 214209 (Sumatriptan), held by Cipla, was first approved by FDA on Feb 22, 2021, with 2 approved supplements and 0 published complete response letters.
Sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before sumatriptan nasal spray is administered to treat any subsequent attacks. Sumatriptan nasal spray is not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sumatriptan20MG/SPRAY · spray;nasal | Sumatriptan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 5, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Feb 22, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
