NDA 19912, held by Blairex. Sodium Chloride.
As of Nov 14, 2026, NDA 19912 (Broncho Saline), held by Blairex, was first approved by FDA on Sep 3, 1992, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 1992 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Broncho Saline0.9% · aerosol, metered;inhalation | Sodium Chloride | DiscontinuedReference drug |
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
