Relieves rhinorrhea associated with the common cold or seasonal allergic rhinitis. ANDA 76598, held by Hikma. Ipratropium Bromide.
As of Nov 15, 2026, ANDA 76598 (Ipratropium Bromide), held by Hikma, was first approved by FDA on Nov 5, 2003, with 1 approved supplement 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 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 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 5, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ipratropium Bromide0.042MG/SPRAY · spray, metered;nasal | Ipratropium Bromide | Rx |
| May 12, 2011 | Supplement 8Labeling | Approved | None posted |
| Nov 5, 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
