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. | 6e2d11f9-94d8-4434-b46b-8e2fcc9276fb | 2025-04-19 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| childrens allergy relief | FLUTICASONE PROPIONATE | Safeway | 44b980b1-660b-4064-8415-87c0c69e48ff | 2025-03-26 | Warnings | FLUTICASONE PROPIONATE |
| Good Sense 24 hour allergy nasal | FLUTICASONE PROPIONATE | RedPharm Drug, Inc | f4c26992-c988-e20f-e053-2a95a90afb65 | 2025-01-23 | Warnings | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Asclemed USA, Inc. | 504397c5-6f9f-45cc-9cc9-997da0a80364 | 2025-01-15 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| FLONASE ALLERGY RELIEF | FLUTICASONE PROPIONATE | Haleon US Holdings LLC | b6134ba0-b70a-4eac-9a82-cef64b242c1d | 2024-12-19 | Warnings | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Quality Care Products, LLC | 1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e | 2024-12-18 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| allergy nasal | FLUTICASONE PROPIONATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2aee623c-602a-407c-b7a3-e29928d7dfed | 2024-12-18 | Warnings | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | A-S Medication Solutions | 3b1849e1-bd0b-42e4-a4ac-f156dc18604a | 2024-11-06 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | faaa1436-dafb-4f65-b062-b51b902f43c5 | 2024-10-29 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Proficient Rx LP | 1d5d5f27-6565-4e7b-9923-faa3d15cb1c4 | 2024-10-01 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Proficient Rx LP | ab8c172b-c369-4372-95f9-dd1a28b3982b | 2024-10-01 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone | FLUTICASONE PROPIONATE | NuCare Pharmaceuticals,Inc. | 549ff4f2-fa68-3dd8-e054-00144ff8d46c | 2024-07-15 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | NuCare Pharmaceuticals,Inc. | 8761a5e1-a9cb-0622-e053-2a95a90a3504 | 2024-06-14 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| CHILDRENS ALLERGY | FLUTICASONE PROPIONATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | b9b3efe4-2f5c-4d22-80a4-d15fb266fb23 | 2024-06-12 | Warnings | FLUTICASONE PROPIONATE |
| fluticasone propionate | FLUTICASONE PROPIONATE | Padagis Israel Pharmaceuticals Ltd | c4d361d4-d480-4fb2-8cc7-4cc3e57838dc | 2024-05-01 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Allegiant Health | 4250d331-17b0-46be-a779-fb4f09bade16 | 2024-04-11 | Warnings | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Bryant Ranch Prepack | 96e0681d-3788-49cc-8c0e-3185675b8da1 | 2024-04-04 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Bryant Ranch Prepack | aed4ac53-cf6e-489e-bb7e-b8c444e4339e | 2024-04-04 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Bryant Ranch Prepack | f6aca9a9-0310-4c11-84b2-eacd19c45a1d | 2024-04-04 | Warnings, Adverse reactions | FLUTICASONE PROPIONATE |
| Fluticasone Propionate | FLUTICASONE PROPIONATE | Bryant Ranch Prepack | 8204a0c2-bd24-409a-b848-b3b369df642f | 2024-03-11 | Warnings, Adverse reactions | 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 |