Application 021433
- Type
- NDA
- Sponsor
- GLAXO GRP LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.22MG/INH | Yes | Yes |
| 002 | FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.11MG/INH | Yes | Yes |
| 003 | FLOVENT HFA | FLUTICASONE PROPIONATE | AEROSOL, METERED;INHALATION | 0.044MG/INH | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021433-001 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | |
| N021433-002 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | |
| N021433-003 | FLOVENT HFA | FLUTICASONE PROPIONATE | 0.044MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2004-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021433-003 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-002 | FLOVENT HFA | 0.11MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021433-003 | FLOVENT HFA | 0.044MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021433-001 | FLOVENT HFA | 0.22MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2004-05-14 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N021433-003 | AB | 1 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | 7500444 | 2026-02-26 | Drug product, Delist requested | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-001 | 7500444*PED | 2026-08-26 | Pediatric extension | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | 7500444 | 2026-02-26 | Drug product, Delist requested | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021433-002 | 7500444*PED | 2026-08-26 | Pediatric extension | d06236e962d9… |
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 HFA | FLUTICASONE PROPIONATE | Preferred Pharmaceuticals Inc. | ff1cf174-ae6f-45f0-a081-26a34e55f9ea | 2026-01-20 | Warnings, Adverse reactions | 021433 NDA021433 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | faaa1436-dafb-4f65-b062-b51b902f43c5 | 2024-10-29 | Warnings, Adverse reactions | 021433 NDA021433 50090-6055 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 674b1c81-359d-4fc4-8ce6-a53931b171e0 | 2024-01-02 | Warnings, Adverse reactions | 021433 NDA021433 50090-6053 |
| FLOVENT HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 74563f7b-8512-4b76-8c55-b88b9cd3206b | 2023-12-09 | Warnings, Adverse reactions | 021433 NDA021433 50090-0934 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | A-S Medication Solutions | 4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d | 2023-11-17 | Warnings, Adverse reactions | 021433 NDA021433 50090-6058 |
| Fluticasone Propionate HFA | FLUTICASONE PROPIONATE | Prasco Laboratories | 99249b31-bf0a-464f-8335-845279350dbe | 2023-09-28 | Warnings, Adverse reactions | 021433 NDA021433 66993-079 66993-078 66993-080 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0718 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0719 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0720 | FLOVENT | fluticasone propionate | GlaxoSmithKline LLC | NDA | Current |
| 50090-0910 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0910 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0910 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0916 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0916 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0916 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0934 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0934 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0934 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-0934 | FLOVENT | fluticasone propionate | A-S Medication Solutions | NDA | Current |
| 50090-6053 | Fluticasone Propionate | fluticasone propionate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-6055 | Fluticasone Propionate | fluticasone propionate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-6058 | Fluticasone Propionate | fluticasone propionate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 53002-1294 | FLOVENT | fluticasone propionate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 53002-1310 | FLOVENT | fluticasone propionate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 53002-1310 | FLOVENT | fluticasone propionate | RPK Pharmaceuticals, Inc. | NDA | Current |
| 66993-078 | Fluticasone Propionate | fluticasone propionate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-079 | Fluticasone Propionate | fluticasone propionate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-080 | Fluticasone Propionate | fluticasone propionate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 68788-6926 | FLOVENT | fluticasone propionate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6926 | FLOVENT | fluticasone propionate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6926 | FLOVENT | fluticasone propionate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6926 | FLOVENT | fluticasone propionate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 68788-6926 | FLOVENT | fluticasone propionate | Preferred Pharmaceuticals Inc. | NDA | Current |
| 70518-0310 | FLOVENT | fluticasone propionate | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68419 | SUPPL | 2021-08-19 |
| 68409 | SUPPL | 2021-08-19 |
| 57519 | SUPPL | 2019-02-13 |
| 57130 | SUPPL | 2019-01-08 |
| 49039 | SUPPL | 2017-07-21 |
| 49027 | SUPPL | 2017-07-20 |
| 45593 | SUPPL | 2016-10-07 |
| 45508 | SUPPL | 2016-10-06 |
| 15451 | SUPPL | 2016-08-02 |
| 5357 | SUPPL | 2016-08-01 |
| 27759 | SUPPL | 2014-12-12 |
| 36911 | SUPPL | 2014-12-11 |
| 5355 | SUPPL | 2014-12-03 |
| 15450 | SUPPL | 2014-11-20 |
| 5356 | SUPPL | 2014-11-17 |
| 36910 | SUPPL | 2013-07-23 |
| 27758 | SUPPL | 2013-07-22 |
| 36909 | SUPPL | 2011-08-05 |
| 5354 | SUPPL | 2010-11-08 |
| 36908 | SUPPL | 2010-11-03 |
| 36907 | SUPPL | 2008-07-09 |
| 5353 | SUPPL | 2008-07-02 |
| 5352 | SUPPL | 2006-10-27 |
| 36906 | SUPPL | 2006-10-26 |
| 36905 | SUPPL | 2006-03-03 |
| 27756 | SUPPL | 2006-03-03 |
| 27757 | SUPPL | 2006-01-18 |
| 15449 | SUPPL | 2006-01-05 |
| 21651 | ORIG | 2005-12-06 |
| 36904 | ORIG | 2004-05-27 |
| 27755 | ORIG | 2004-05-26 |
| 63520 | ORIG | 1900-01-01 |