Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214464
Company: RESPIRENT PHARMS
Company: RESPIRENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.1MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Discontinued | None | No | No |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.25MG/INH;EQ 0.05MG BASE/INH | POWDER;INHALATION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/12/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |