Application 020837
- Type
- NDA
- Sponsor
- OAK PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.021% BASE | Yes | Yes |
| 002 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.042% BASE | Yes | Yes |
| 003 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.0103% BASE | Yes | Yes |
| 004 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.25% BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020837-001 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | |
| N020837-002 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | |
| N020837-003 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | |
| N020837-004 | XOPENEX | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020837-001 | XOPENEX | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020837-002 | XOPENEX | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 1999-03-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020837-003 | XOPENEX | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2002-01-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020837-004 | XOPENEX | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2003-07-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020837-001 | XOPENEX | EQ 0.021% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020837-002 | XOPENEX | EQ 0.042% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020837-003 | XOPENEX | EQ 0.0103% BASE | SOLUTION / INHALATION | RLD | 2002-01-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020837-004 | XOPENEX | EQ 0.25% BASE | SOLUTION / INHALATION | RLD | 2003-07-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020837-001 | XOPENEX | EQ 0.021% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020837-002 | XOPENEX | EQ 0.042% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020837-003 | XOPENEX | EQ 0.0103% BASE | SOLUTION / INHALATION | RLD | 2002-01-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020837-004 | XOPENEX | EQ 0.25% BASE | SOLUTION / INHALATION | RLD | 2003-07-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020837-001 | XOPENEX | EQ 0.021% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020837-002 | XOPENEX | EQ 0.042% BASE | SOLUTION / INHALATION | RLD | 1999-03-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020837-003 | XOPENEX | EQ 0.0103% BASE | SOLUTION / INHALATION | RLD | 2002-01-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020837-004 | XOPENEX | EQ 0.25% BASE | SOLUTION / INHALATION | RLD | 2003-07-18 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020837-001 | AN | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020837-002 | AN | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020837-003 | AN | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020837-004 | AN | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020837-001 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020837-002 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020837-003 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020837-004 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020837-001 | AN | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020837-002 | AN | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020837-003 | AN | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020837-004 | AN | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020837-001 | AN | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020837-002 | AN | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020837-003 | AN | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020837-004 | AN | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020837-001 | AN | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020837-002 | AN | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020837-003 | AN | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020837-004 | AN | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020837-001 | AN | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020837-002 | AN | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020837-003 | AN | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020837-004 | AN | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-001 | AN | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-002 | AN | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-003 | AN | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-004 | AN | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020837-001 | AN | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020837-002 | AN | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020837-003 | AN | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020837-004 | AN | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020837-001 | AN | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020837-002 | AN | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020837-003 | AN | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020837-004 | AN | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020837-001 | AN | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020837-002 | AN | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020837-003 | AN | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020837-004 | AN | 1 | c0c555d07b60… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020837-001 | 6451289 | 2021-03-21 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N020837-002 | 6451289 | 2021-03-21 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N020837-003 | 6451289 | 2021-03-21 | 74a2ff9319b5… | |||
| 2019-12-13 00:20 UTC | 2019-12 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020837-001 | 6451289 | 2021-03-21 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N020837-002 | 6451289 | 2021-03-21 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N020837-003 | 6451289 | 2021-03-21 | 782e0a99824c… | |||
| 2021-12-28 21:50 UTC | 2021-12 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-001 | 6451289 | 2021-03-21 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-002 | 6451289 | 2021-03-21 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-003 | 6451289 | 2021-03-21 | 87673890dc5c… | |||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020837-001 | 6451289 | 2021-03-21 | 5aa47cf7b7d7… | |||
| 2021-03-12 10:30 UTC | 2021-03 | N020837-002 | 6451289 | 2021-03-21 | 5aa47cf7b7d7… | |||
| 2021-03-12 10:30 UTC | 2021-03 | N020837-003 | 6451289 | 2021-03-21 | 5aa47cf7b7d7… | |||
| 2021-03-12 10:30 UTC | 2021-03 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020837-001 | 6451289 | 2021-03-21 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N020837-002 | 6451289 | 2021-03-21 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N020837-003 | 6451289 | 2021-03-21 | 8869cabd3fbd… | |||
| 2020-12-22 03:56 UTC | 2020-12 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020837-001 | 6451289 | 2021-03-21 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N020837-002 | 6451289 | 2021-03-21 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N020837-003 | 6451289 | 2021-03-21 | c0c555d07b60… | |||
| 2020-11-12 02:37 UTC | 2020-11 | N020837-004 | 6451289 | 2021-03-21 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020837-001 | 6451289 | 2021-03-21 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N020837-002 | 6451289 | 2021-03-21 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N020837-003 | 6451289 | 2021-03-21 | 3f01610625f2… | |||
| 2019-12-14 00:12 UTC | 2019-12 | N020837-004 | 6451289 | 2021-03-21 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020837-001 | 6451289 | 2021-03-21 | b00525d2431f… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N020837-002 | 6451289 | 2021-03-21 | b00525d2431f… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N020837-003 | 6451289 | 2021-03-21 | b00525d2431f… | |||
| 2019-09-15 20:21 UTC | 2019-09 | N020837-004 | 6451289 | 2021-03-21 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020837-001 | 6451289 | 2021-03-21 | ea99ee380514… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N020837-002 | 6451289 | 2021-03-21 | ea99ee380514… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N020837-003 | 6451289 | 2021-03-21 | ea99ee380514… | |||
| 2019-07-19 19:46 UTC | 2019-07 | N020837-004 | 6451289 | 2021-03-21 | Drug product | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Redpharm Drug | 58beb877-b94a-bbe0-e063-6294a90a7fe0 | 2026-08-11 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Redpharm Drug | 56cb1f4b-ddf4-0661-e063-6394a90a9c45 | 2026-07-17 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Ritedose Pharmaceuticals, LLC | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 2025-12-10 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | e7e3d858-6a0d-482c-b71b-de90d3ef3169 | 2023-09-14 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | d4080fc5-50d6-49a9-8a63-7769d201968d | 2023-09-14 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Bryant Ranch Prepack | 2f416dc8-62aa-4b6b-a745-2c8a72bb763d | 2023-09-13 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | A-S Medication Solutions | 262c0b8b-8461-4bdf-b272-c829d33fd451 | 2023-02-28 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Burel Pharmaceuticals, LLC | 737fe40b-798b-4d7f-bec9-7af952018ab5 | 2021-07-01 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
| Levalbuterol | LEVALBUTEROL HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | e5c8368a-49f9-45cf-9d42-a871f005edb9 | 2019-06-29 | Warnings, Adverse reactions | LEVALBUTEROL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-171 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-171 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-171 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-171 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-171 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-172 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-173 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride | Akorn | NDA | Current |
| 17478-174 | Xopenex | Levalbuterol Hydrochloride | Akorn, Inc. | NDA | Current |
| 21695-153 | Xopenex | levalbuterol hydrochloride | Rebel Distributors Corp | NDA | Current |
| 66993-021 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-021 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-021 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-021 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-021 | Levalbuterol Hydrochloride | Levalbuterol hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-022 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-022 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-022 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-022 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-022 | Levalbuterol Hydrochloride | levalbuterol hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-023 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-023 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-023 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-023 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Prasco Laboratories | NDA | Current |
| 66993-023 | Levalbuterol hydrochloride | levalbuterol hydrochloride | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 70518-1227 | Xopenex | Levalbuterol Hydrochloride | REMEDYREPACK INC. | NDA | Current |
| 76204-002 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Ritedose Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 76204-003 | Levalbuterol Hydrochloride | Levalbuterol Hydrochloride | Ritedose Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57234 | SUPPL | 2019-01-16 |
| 57120 | SUPPL | 2019-01-04 |
| 13572 | SUPPL | 2015-04-14 |
| 3522 | SUPPL | 2015-04-02 |
| 13571 | SUPPL | 2015-01-29 |
| 3521 | SUPPL | 2015-01-23 |
| 26010 | SUPPL | 2014-04-02 |
| 35478 | SUPPL | 2014-04-01 |
| 3520 | SUPPL | 2014-01-22 |
| 35477 | SUPPL | 2013-09-24 |
| 26009 | SUPPL | 2013-09-23 |
| 13570 | SUPPL | 2012-09-11 |
| 3519 | SUPPL | 2012-09-10 |
| 41743 | SUPPL | 2006-10-26 |
| 26008 | SUPPL | 2006-09-18 |
| 26007 | SUPPL | 2003-07-28 |
| 13569 | SUPPL | 2002-01-30 |
| 26006 | ORIG | 1999-03-25 |
| 20999 | ORIG | 1999-03-25 |
| 13568 | ORIG | 1999-03-25 |
| 51290 | SUPPL | 1900-01-01 |
| 51289 | SUPPL | 1900-01-01 |
| 51288 | SUPPL | 1900-01-01 |