NDA 21127, held by Rising. Azelastine Hydrochloride.
As of Nov 13, 2026, NDA 21127 (Optivar), held by Rising, was first approved by FDA on May 22, 2000, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Optivar0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Azelastine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2025 | Supplement 18Labeling · Standard review | Approved | |
| Jul 3, 2008 | Supplement 13Manufacturing | Approved | |
| Sep 3, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Apr 30, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Apr 30, 2004 | Supplement 8Labeling · Standard review | Approved | |
| May 4, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Apr 4, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 22, 2000 | Original applicationNew dosage form · Standard review | Approved |
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
