Application 020949
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACCUNEB | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.042% BASE | Yes | Yes |
| 002 | ACCUNEB | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.021% BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020949-001 | ACCUNEB | ALBUTEROL SULFATE | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | |
| N020949-002 | ACCUNEB | ALBUTEROL SULFATE | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020949-001 | ACCUNEB | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020949-002 | ACCUNEB | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | RLD | 2001-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020949-001 | ACCUNEB | EQ 0.042% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020949-002 | ACCUNEB | EQ 0.021% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020949-001 | ACCUNEB | EQ 0.042% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020949-002 | ACCUNEB | EQ 0.021% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020949-001 | ACCUNEB | EQ 0.042% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020949-002 | ACCUNEB | EQ 0.021% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020949-001 | ACCUNEB | EQ 0.042% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020949-002 | ACCUNEB | EQ 0.021% BASE | SOLUTION / INHALATION | AN | RLD, RS | 2001-04-30 | 74a2ff9319b5… |
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 | N020949-001 | AN | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020949-002 | AN | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020949-001 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N020949-002 | AN | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020949-001 | AN | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N020949-002 | AN | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020949-001 | AN | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020949-002 | AN | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020949-001 | AN | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N020949-002 | AN | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020949-001 | AN | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N020949-002 | AN | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020949-001 | AN | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020949-002 | AN | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020949-001 | AN | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N020949-002 | AN | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020949-001 | AN | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N020949-002 | AN | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020949-001 | AN | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020949-002 | AN | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020949-001 | AN | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020949-002 | AN | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020949-001 | AN | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020949-002 | AN | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020949-001 | AN | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020949-002 | AN | 1 | ea99ee380514… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020949-002 | AN | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020949-002 | AN | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020949-002 | AN | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020949-001 | AN | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020949-002 | AN | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020949-001 | AN | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N020949-002 | AN | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020949-001 | AN | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N020949-002 | AN | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020949-001 | AN | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020949-002 | AN | 1 | cb3db0bc1861… |
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 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020949-001 | 6702997 | 2021-12-28 | U-558 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020949-002 | 6702997 | 2021-12-28 | U-558 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020949-001 | 6702997 | 2021-12-28 | U-558 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020949-001 | 6702997 | 2021-12-28 | U-558 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020949-002 | 6702997 | 2021-12-28 | U-558 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020949-001 | 6702997 | 2021-12-28 | U-558 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020949-002 | 6702997 | 2021-12-28 | U-558 | 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 |
|---|---|---|---|---|---|---|
| Albuterol Sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 081b7bbb-6692-4512-b135-863b73bf30a5 | 2025-10-13 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulate HFA | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 825975b1-a4a9-78ca-e053-2a91aa0a3948 | 2025-09-02 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | QUAGEN PHARMACEUTICALS LLC | 99a490cc-e41d-436b-9cf3-8facb7ac714f | 2025-07-03 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 99782bc8-56d9-41f8-935e-0d0de27f0c34 | 2025-05-19 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Preferred Pharmaceuticals Inc. | 1c72fd84-7dbc-45d0-ab88-fb4221ce369f | 2025-05-16 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Asclemed USA, Inc. | 264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47 | 2025-05-07 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Proficient Rx LP | a6545fbe-b0a6-41ae-8bb6-91af38410f56 | 2025-04-01 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | Chartwell RX, LLC | 560df50c-e2c4-459f-9d89-bf7e6588949e | 2025-03-28 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Nephron Pharmaceuticals Corporation | ecc00500-58b8-491f-80df-dc6c89a08cae | 2025-03-21 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 813d49be-3651-6759-e053-2991aa0a6a9f | 2025-02-06 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Lupin Pharmaceuticals, Inc. | 973b8686-c6ce-4280-85c4-c1e7ceab3c09 | 2025-01-23 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | A-S Medication Solutions | 52e209ac-7156-4496-ba5a-42ee59d45deb | 2025-01-22 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals,Inc. | 749992b4-69e0-0cc8-e053-2991aa0aeb25 | 2025-01-08 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | HF Acquisition Co LLC, DBA HealthFirst | 9d4ef83f-8ca0-811e-e053-2995a90a6d0d | 2025-01-08 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | Preferred Pharmaceuticals, Inc. | 4aafc2dd-744d-4726-828f-70355aee6f70 | 2025-01-03 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Proficient Rx LP | 53eecdef-a7ff-4ca3-a313-d4b9c29c898d | 2025-01-01 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate HFA | ALBUTEROL SULFATE | Advanced Rx of Tennessee, LLC | 04c8a345-0a0d-5a01-e063-6294a90a40d2 | 2024-12-31 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Advanced Rx Pharmacy of Tennessee, LLC | f44b325d-0f74-552c-e053-2995a90ac1c9 | 2024-12-31 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate Inhalation | ALBUTEROL SULFATE | Amneal Pharmaceuticals NY LLC | 2e449282-ee58-4e36-b983-85c4e6f0864d | 2024-12-20 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Ingenus Pharmaceuticals, LLC | e14f5fd6-d01a-489d-9baa-61778b1352a8 | 2024-10-22 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6991 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |
| 0378-6992 | Albuterol Sulfate | albuterol sulfate | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | Current |