Application 021254
- Type
- NDA
- Sponsor
- GLAXO GRP LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.045MG/INH;EQ 0.021MG BASE/INH | Yes | Yes |
| 002 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.115MG/INH;EQ 0.021MG BASE/INH | Yes | Yes |
| 003 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | AEROSOL, METERED;INHALATION | 0.23MG/INH;EQ 0.021MG BASE/INH | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021254-001 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | |
| N021254-002 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | |
| N021254-003 | ADVAIR HFA | FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 |
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 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021254-002 | ADVAIR HFA | 0.115MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021254-003 | ADVAIR HFA | 0.23MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021254-001 | ADVAIR HFA | 0.045MG/INH;EQ 0.021MG BASE/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-06-08 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-001 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7832351 | 2023-06-19 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-002 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7832351 | 2023-06-19 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7832351*PED | 2023-12-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7500444 | 2026-02-26 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021254-003 | 7500444*PED | 2026-08-26 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7350676*PED | 2019-02-24 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 9861771 | 2020-10-11 | Drug product | 2018-03-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7832351 | 2023-06-19 | Drug product | 2012-09-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021254-001 | 7832351*PED | 2023-12-19 | Pediatric extension | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| ADVAIR HFA | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | A-S Medication Solutions | 80b36523-4ae4-463e-b1fd-b929fb802b76 | 2025-08-08 | Warnings, Adverse reactions | 021254 NDA021254 |
| ADVAIR HFA | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | A-S Medication Solutions | 223fd5d4-3bd2-4e45-b72e-699438c32206 | 2025-08-08 | Warnings, Adverse reactions | 021254 NDA021254 |
| Fluticasone Propionate and Salmeterol HFA | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | Prasco Laboratories | 666c5b12-a4f7-4c53-8261-4742b5e5a6df | 2024-05-29 | Warnings, Adverse reactions | 021254 NDA021254 |
| ADVAIR HFA | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | GlaxoSmithKline LLC | dfaca6f9-3277-47b2-319d-1377917cb54c | 2024-05-23 | Warnings, Adverse reactions | 021254 NDA021254 0173-0717 0173-0716 0173-0715 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0715 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0716 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
| 0173-0717 | ADVAIR HFA | fluticasone propionate and salmeterol xinafoate | GlaxoSmithKline LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68420 | SUPPL | 2021-08-19 |
| 68408 | SUPPL | 2021-08-19 |
| 57518 | SUPPL | 2019-02-13 |
| 57131 | SUPPL | 2019-01-08 |
| 50875 | SUPPL | 2017-12-27 |
| 50841 | SUPPL | 2017-12-22 |
| 47492 | SUPPL | 2017-03-08 |
| 47457 | SUPPL | 2017-03-03 |
| 36479 | SUPPL | 2014-12-20 |
| 4798 | SUPPL | 2014-12-12 |
| 36480 | SUPPL | 2014-12-11 |
| 4797 | SUPPL | 2014-11-14 |
| 27227 | SUPPL | 2012-12-21 |
| 14761 | SUPPL | 2012-12-21 |
| 4796 | SUPPL | 2012-08-13 |
| 27231 | SUPPL | 2011-07-05 |
| 36478 | SUPPL | 2011-05-16 |
| 27230 | SUPPL | 2011-05-12 |
| 27228 | SUPPL | 2011-01-07 |
| 27229 | SUPPL | 2010-06-29 |
| 14762 | SUPPL | 2010-06-28 |
| 4795 | SUPPL | 2009-10-26 |
| 36477 | SUPPL | 2009-09-21 |
| 4794 | SUPPL | 2008-08-05 |
| 21551 | ORIG | 2008-05-06 |
| 36476 | SUPPL | 2008-03-24 |
| 4793 | SUPPL | 2008-03-21 |
| 23639 | ORIG | 2006-06-19 |
| 36475 | ORIG | 2006-06-14 |
| 4792 | ORIG | 2006-06-14 |
| 51121 | SUPPL | 1900-01-01 |
| 51120 | SUPPL | 1900-01-01 |
| 51119 | SUPPL | 1900-01-01 |