FDF Products - Inhalation
| Product | Strength | Formulation | Filing |
|---|---|---|---|
| Budesonide | 0.25mg/ml, 0.5mg/ml | Soft Mist Inhaler | 505(b)(2) |
| Budesonide and Formoterol | 80 mcg/ 160 mcg budesonide+ 4.5 mcg formoterol | Soft Mist Inhaler | 505(b)(2) |
| Budesonide, Formoterol, Glycopyrrolate | Soft Mist Inhaler | 505(b)(2) | |
| Fenoterol + Ipratropium Bromide | 20 mcg Fenoterol +50 mcg ipratropium bromide per puff | Soft Mist Inhaler | 505(b)(2) |
| Fluticasone Furoate, Vilanterol Trifenatate, Umeclidinium Bromide | Fluticasone Furoate 100 or 200 micrograms, umeclidinium (as bromide) 62.5 micrograms and vilanterol (as trifenatate) 25 micrograms per inhalation | Soft Mist Inhaler | 505(b)(2) |
| Ipratropium Bromide + Albuterol | 20 mcg Ipratropium Bromide + 100 mcg albuterol per puff | Soft Mist Inhaler | ANDA |
| Olodaterol | 2.5 mcg per puff | Soft Mist Inhaler | ANDA |
| Tiotropium Bromide | 2.5 mcg per puff | Soft Mist Inhaler | ANDA |
| Tiotropium Bromide + Olodaterol | 2.5 mcg Tiotropium + 2.5 mcg Olodaterol per puff | Soft Mist Inhaler | ANDA |
