Relieves rhinorrhea associated with the common cold or seasonal allergic rhinitis. ANDA 219221, held by Rubicon Research. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 219221 (Ipratropium Bromide), held by Rubicon Research, was first approved by FDA on Nov 15, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ipratropium Bromide Nasal Solution, 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.042MG/SPRAY · spray, metered;nasal | Ipratropium Bromide | Rx |
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
