NDA 18000, held by Sanofi Aventis US. Terbutaline Sulfate.
As of Nov 13, 2026, NDA 18000 (Bricanyl), held by Sanofi Aventis US, was first approved by FDA on Mar 19, 1985, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 1985 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bricanyl0.2MG/INH · aerosol, metered;inhalation | Terbutaline Sulfate | Discontinued |
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
