Drug application
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE)
Drugs@FDA ANDA 214464 · RESPIRENT PHARMS
Key facts
| Drug name | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
|---|---|
| Active ingredients | FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE |
| Application type | ANDA |
| Application number | 214464 |
| Company | RESPIRENT PHARMS |
| Dosage forms | POWDER, INHALATION |
| Strength | 0.1MG/INH;EQ 0.05MG BASE/INH |
| Marketing status | Prescription |
| TE codes | AB |
| Reference listed drug | No |
| Latest submission status date | Jan 12, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.