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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020548-001 | FLOVENT | FLUTICASONE PROPIONATE | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | ||
| N020548-002 | FLOVENT | FLUTICASONE PROPIONATE | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | ||
| N020548-003 | FLOVENT | FLUTICASONE PROPIONATE | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020548-002 | FLOVENT | 0.11MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020548-003 | FLOVENT | 0.22MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020548-001 | FLOVENT | 0.044MG/INH | AEROSOL, METERED / INHALATION | 1996-03-27 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Asclemed USA, Inc. | 75049554-64ca-4efa-b8d1-13cf31d0ff90 | 2022-10-12 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Cosette Pharmaceuticals, Inc. | 14c8d082-b301-8f09-a509-950459ae0a28 | 2022-05-05 | Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Glenmark Pharmaceuticals Inc., USA | 3c7b3482-e2fd-4857-9394-a47fd7f4c47b | 2020-02-01 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | Proficient Rx LP | 96af29b8-16b4-4113-9ec3-338438e11a49 | 2019-11-01 | Adverse reactions | FLUTICASONE PROPIONATE |
| FLOVENT DISKUS | FLUTICASONE PROPIONATE | Proficient Rx LP | 816e929e-6ba0-437d-80bb-00068419ed53 | 2019-11-01 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Selder, S.A. de C.V. | 2da4ba91-c356-473d-b20c-5bb9265767df | 2017-11-29 | Warnings | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Allegiant Health | 4e1cd546-4598-115b-0357-5d0c22731faa | 2017-11-17 | Warnings | FLUTICASONE PROPIONATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |