Application 020121
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLONASE | FLUTICASONE PROPIONATE | SPRAY, METERED;NASAL | 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57512 | SUPPL | 2019-02-13 |
| 57134 | SUPPL | 2019-01-08 |
| 12230 | SUPPL | 2015-01-30 |
| 21180 | SUPPL | 2015-01-26 |
| 41146 | SUPPL | 2010-05-25 |
| 21179 | SUPPL | 2004-04-07 |
| 12229 | SUPPL | 2004-04-05 |
| 2037 | SUPPL | 2003-05-30 |
| 34276 | SUPPL | 2003-05-06 |
| 2036 | SUPPL | 2002-05-23 |
| 21178 | SUPPL | 2002-05-09 |
| 2035 | SUPPL | 2002-05-09 |
| 2034 | SUPPL | 2002-05-09 |
| 41147 | SUPPL | 1998-12-11 |
| 12228 | SUPPL | 1998-12-11 |
| 2033 | SUPPL | 1998-12-11 |
| 53096 | ORIG | 1900-01-01 |
| 53095 | ORIG | 1900-01-01 |
| 53094 | ORIG | 1900-01-01 |
| 53093 | ORIG | 1900-01-01 |
| 53092 | ORIG | 1900-01-01 |
| 53091 | ORIG | 1900-01-01 |
| 53090 | ORIG | 1900-01-01 |
| 53089 | ORIG | 1900-01-01 |
| 53088 | ORIG | 1900-01-01 |