Application 020911
- Type
- NDA
- Sponsor
- TEVA BRANDED PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QVAR 80 | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | QVAR 40 | BECLOMETHASONE DIPROPIONATE | AEROSOL, METERED;INHALATION | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020911-001 | QVAR 80 | BECLOMETHASONE DIPROPIONATE | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | |
| N020911-002 | QVAR 40 | BECLOMETHASONE DIPROPIONATE | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N020911-001 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | |
| N020911-001 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | |
| N020911-001 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | |
| N020911-001 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | |
| N020911-001 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | |
| N020911-002 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | |
| N020911-002 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | |
| N020911-002 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | |
| N020911-002 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | |
| N020911-002 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 |
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 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020911-001 | QVAR 80 | 0.08MG/INH | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020911-002 | QVAR 40 | 0.04MG/INH | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020911-001 | QVAR 80 | 0.08MG/INH | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020911-002 | QVAR 40 | 0.04MG/INH | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020911-001 | QVAR 80 | 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020911-002 | QVAR 40 | 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | AEROSOL, METERED / INHALATION | RLD | 2000-09-15 | 782e0a99824c… |
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 | N020911-001 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-001 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-001 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-001 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-001 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020911-002 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-001 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | 10022509 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | 10022510 | 2031-05-18 | Drug product, Delist requested | 2018-08-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | 10086156 | 2031-05-18 | Drug product, Delist requested | 2018-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020911-002 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-001 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 10022509 | 2031-05-18 | Drug product | 2018-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 10022510 | 2031-05-18 | Drug product | 2018-08-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 10086156 | 2031-05-18 | Drug product | 2018-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 10695512 | 2031-05-18 | Drug product | 2020-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 9463289 | 2031-05-18 | Drug product, Delist requested | 2016-11-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020911-002 | 9808587 | 2031-05-18 | Drug product, Delist requested | 2017-11-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 10022509 | 2031-05-18 | Drug product | 2018-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 10022510 | 2031-05-18 | Drug product | 2018-08-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 10086156 | 2031-05-18 | Drug product | 2018-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 10695512 | 2031-05-18 | Drug product | 2020-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 11395889 | 2031-05-18 | Drug product | 2022-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 9463289 | 2031-05-18 | Drug product | 2016-11-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 9808587 | 2031-05-18 | Drug product | 2017-11-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020911-001 | 10561808 | 2032-01-01 | Drug product | 2020-03-19 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| QNASL | BECLOMETHASONE DIPROPIONATE | Teva Respiratory, LLC | 4b8d8e84-b5d2-4e56-97ec-4f72971465c5 | 2022-09-27 | Warnings, Adverse reactions | BECLOMETHASONE DIPROPIONATE |
| Beclomethasone Dipropionate | BECLOMETHASONE DIPROPIONATE | Amneal Pharmaceuticals NY LLC | d853c96f-21a3-4def-931d-4d47d16acd62 | 2020-07-31 | Warnings, Adverse reactions | BECLOMETHASONE DIPROPIONATE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-1342 | QVAR | Beclomethasone Dipropionate | A-S Medication Solutions | NDA | Current |
| 50090-3033 | QVAR | Beclomethasone Dipropionate | A-S Medication Solutions | NDA | Current |
| 59310-202 | QVAR | Beclomethasone Dipropionate | Teva Respiratory, LLC | NDA | Current |
| 59310-202 | QVAR | Beclomethasone Dipropionate | Teva Respiratory, LLC | NDA | Current |
| 59310-204 | QVAR | Beclomethasone Dipropionate | Teva Respiratory, LLC | NDA | Current |
| 59310-204 | QVAR | Beclomethasone Dipropionate | Teva Respiratory, LLC | NDA | Current |
| 68071-1691 | QVAR | Beclomethasone Dipropionate | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68788-7025 | QVAR | beclomethasone dipropionate | Preferred Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64279 | SUPPL | 2020-08-13 |
| 64278 | SUPPL | 2020-08-13 |
| 49932 | SUPPL | 2017-10-03 |
| 49931 | SUPPL | 2017-10-03 |
| 49913 | SUPPL | 2017-10-03 |
| 49912 | SUPPL | 2017-10-03 |
| 35631 | SUPPL | 2014-07-30 |
| 3727 | SUPPL | 2014-07-24 |
| 13727 | SUPPL | 2014-05-28 |
| 3728 | SUPPL | 2014-05-23 |
| 3726 | SUPPL | 2012-08-01 |
| 35630 | SUPPL | 2012-07-30 |
| 35629 | SUPPL | 2008-08-26 |
| 3725 | SUPPL | 2008-08-20 |
| 35628 | SUPPL | 2007-01-16 |
| 3724 | SUPPL | 2006-11-22 |
| 13726 | ORIG | 2004-06-14 |
| 3722 | ORIG | 2004-06-14 |
| 41806 | ORIG | 2004-02-11 |
| 26177 | SUPPL | 2003-08-15 |
| 3723 | SUPPL | 2002-05-09 |