Application 020833
- Type
- NDA
- Sponsor
- GLAXO GRP LTD
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLOVENT DISKUS 50 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.05MG/INH | Yes | Yes |
| 002 | FLOVENT DISKUS 100 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.1MG/INH | Yes | Yes |
| 003 | FLOVENT DISKUS 250 | FLUTICASONE PROPIONATE | POWDER;INHALATION | 0.25MG/INH | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0600 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0601 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0602 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 50090-1245 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 63187-957 | FLOVENT | fluticasone propionate | Proficient Rx LP | NDA | Current |
| 63187-957 | FLOVENT | fluticasone propionate | Proficient Rx LP | NDA | Current |
| 76519-1177 | FLOVENT | FLUTICASONE PROPIONATE | H.J. Harkins Company, Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 57516 | SUPPL | 2019-02-13 |
| 57133 | SUPPL | 2019-01-08 |
| 49038 | SUPPL | 2017-07-21 |
| 49026 | SUPPL | 2017-07-20 |
| 45594 | SUPPL | 2016-10-07 |
| 45509 | SUPPL | 2016-10-06 |
| 13554 | SUPPL | 2016-08-02 |
| 3500 | SUPPL | 2016-08-01 |
| 25993 | SUPPL | 2014-11-14 |
| 35467 | SUPPL | 2014-04-16 |
| 3499 | SUPPL | 2014-04-16 |
| 25992 | SUPPL | 2010-05-05 |
| 35466 | SUPPL | 2010-05-04 |
| 13553 | SUPPL | 2005-09-15 |
| 3498 | SUPPL | 2005-09-15 |
| 35465 | SUPPL | 2005-08-03 |
| 25991 | SUPPL | 2005-08-03 |
| 13552 | SUPPL | 2004-12-30 |
| 3497 | SUPPL | 2004-12-30 |
| 41738 | ORIG | 2004-12-07 |
| 25990 | SUPPL | 2002-11-01 |
| 3496 | SUPPL | 2002-11-01 |
| 3495 | ORIG | 2000-09-29 |