Application 213811
- Type
- ANDA
- Sponsor
- AMNEAL IRELAND LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BECLOMETHASONE DIPROPIONATE | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.04MG/INH | No | Yes |
| 002 | BECLOMETHASONE DIPROPIONATE | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.08MG/INH | No | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83997 | ORIG | 2026-01-13 |