Treats nasal symptoms of seasonal or perennial rhinitis. ANDA 74805, held by Bausch. Flunisolide.
As of Nov 14, 2026, ANDA 74805 (Flunisolide), held by Bausch, was first approved by FDA on Feb 20, 2002, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Flunisolide Nasal Solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide Nasal Solution should not be used in the presence of untreated localized infection involving nasal mucosa.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 20, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flunisolide0.025MG/SPRAY · spray, metered;nasal | Flunisolide | Rx |
| Dec 12, 2024 | Supplement 22Manufacturing | Approved | None posted |
| May 18, 2004 | Supplement 3Labeling | Approved | None posted |
| Feb 20, 2002 | Original application | 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
