Relieves rhinorrhea associated with the common cold or seasonal allergic rhinitis. ANDA 76103, held by Bausch. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 76103 (Ipratropium Bromide), held by Bausch, was first approved by FDA on Mar 31, 2003, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) 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% (Nasal Spray) 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% (Nasal Spray) 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 |
|---|---|---|---|
| Mar 31, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.042MG/SPRAY · spray, metered;nasal | Ipratropium Bromide | Rx |
| Feb 6, 2012 | Supplement 7Labeling | Approved | None posted |
| Mar 12, 2008 | Supplement 5Labeling | Approved | None posted |
| Jan 27, 2005 | Supplement 1Labeling | Approved | None posted |
| Mar 31, 2003 | 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
