Manages cystic fibrosis. ANDA 205501, held by Amneal Pharms. Tobramycin.
As of Nov 15, 2026, ANDA 205501 (Tobramycin), held by Amneal Pharms, was first approved by FDA on Jul 13, 2015, with 2 approved supplements and 0 published complete response letters.
Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Rx |
| Jul 10, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 21, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 13, 2015 | 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
