Treats bronchospasm associated with chronic obstructive pulmonary disease (COPD)…. ANDA 211287, held by Lupin. Tiotropium Bromide.
As of Nov 15, 2026, ANDA 211287 (Tiotropium Bromide), held by Lupin, was first approved by FDA on Jun 20, 2023, with 0 approved supplements and 0 published complete response letters.
Tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tiotropium bromide inhalation powder is indicated to reduce exacerbations in COPD patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tiotropium BromideEQ 0.018MG BASE/INH · powder;inhalation | Tiotropium Bromide | Rx |
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
