Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213811
Company: AMNEAL IRELAND LTD
Company: AMNEAL IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BECLOMETHASONE DIPROPIONATE | BECLOMETHASONE DIPROPIONATE | 0.04MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | No | Yes |
| BECLOMETHASONE DIPROPIONATE | BECLOMETHASONE DIPROPIONATE | 0.08MG/INH | AEROSOL, METERED;INHALATION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/16/2025 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213811Orig1s000ltr.pdf |