Application 020548
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.044MG/INH | No | No |
| 002 | FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.11MG/INH | No | No |
| 003 | FLOVENT | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.22MG/INH | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 25154 | SUPPL | 2004-04-07 |
| 12711 | SUPPL | 2004-04-05 |
| 12710 | SUPPL | 2003-10-16 |
| 2703 | SUPPL | 2003-10-16 |
| 34810 | SUPPL | 2003-07-08 |
| 25153 | SUPPL | 2003-07-06 |
| 20713 | SUPPL | 1998-12-22 |
| 63715 | ORIG | 1900-01-01 |
| 51956 | ORIG | 1900-01-01 |
| 51955 | ORIG | 1900-01-01 |
| 51954 | ORIG | 1900-01-01 |
| 51953 | ORIG | 1900-01-01 |
| 51952 | ORIG | 1900-01-01 |
| 51951 | ORIG | 1900-01-01 |
| 51950 | ORIG | 1900-01-01 |
| 51948 | ORIG | 1900-01-01 |