Application 019269
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | VENTOLIN | ALBUTEROL SULFATE | SOLUTION;INHALATION | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019269-002 | VENTOLIN | ALBUTEROL SULFATE | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 |
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| 2026-08 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019269-002 | VENTOLIN | EQ 0.5% BASE | SOLUTION / INHALATION | 1987-01-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019269-002 | VENTOLIN | EQ 0.5% BASE | SOLUTION / INHALATION | 1987-01-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION / INHALATION | 1987-01-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019269-002 | VENTOLIN | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | 1987-01-16 | f41ea6bd6efb… |
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 | Armstrong Pharmaceuticals, Inc. | 17858afa-dcdf-4612-b475-3b6baadfb639 | 2026-08-06 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | NuCare Pharmaceuticals, Inc. | 583c6408-45cc-9121-e063-6294a90afcc4 | 2026-08-04 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Rising Pharma Holdings, Inc. | 3236f82c-14e9-dfd4-e063-6294a90ac43d | 2026-07-16 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Rising Pharma Holdings, Inc. | 32377c09-da6d-331c-e063-6294a90a7a46 | 2026-07-16 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Rising Pharma Holdings, Inc | 32474c0e-af35-69d1-e063-6394a90a53c6 | 2026-07-16 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | HAWAII REPACK, INC. | b18fad6e-f117-4840-83b7-8c261c646af1 | 2026-07-03 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | American Health Packaging | 4aec7f59-b429-4b0e-a779-8df1dd8f80d7 | 2026-06-23 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | REMEDYREPACK INC. | 0f9bf2c8-55c0-4b4d-97de-d6c7220c3862 | 2026-06-17 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | Cipla USA Inc. | c4d6d76a-14b8-411a-8019-e2c923c2c532 | 2026-05-20 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | American Health Packaging | b0a5da99-6553-4088-ae27-7fa194438340 | 2026-05-20 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate Inhalation Solution, 0.5% | ALBUTEROL SULFATE | Ritedose Pharmaceuticals, LLC | fdb4ac5a-bf0d-4896-89f7-1828c081b79e | 2026-04-30 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate Inhalation Solution | ALBUTEROL SULFATE | Ritedose Pharmaceuticals, LLC | d4c532be-1f41-60d3-e053-2995a90a98be | 2026-04-30 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Ritedose Pharmaceuticals, LLC | b72742df-1a6b-4483-aff3-3e79db5e015d | 2026-04-30 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| albuterol sulfate | ALBUTEROL SULFATE | Sportpharm LLC | 440a96bb-9e69-bdcc-e063-6294a90a6793 | 2026-04-24 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Sportpharm LLC | a33e20e0-3936-450d-a9d9-3ff51c6f26c5 | 2026-04-24 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Sportpharm LLC | e31d8d13-ac19-4738-97d4-d7790ce2e8e3 | 2026-04-24 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | Sportpharm LLC | 32d954ee-9790-4beb-95db-72dbf8efa639 | 2026-04-24 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol Sulfate | ALBUTEROL SULFATE | Cardinal Health 107, LLC | d2132c1c-0f90-4c6f-afc0-f3814b6a7e5c | 2026-04-20 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| albuterol sulfate | ALBUTEROL SULFATE | Golden State Medical Supply, Inc. | a22af54a-c010-ab8b-e053-2a95a90a8862 | 2026-04-15 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
| Albuterol sulfate | ALBUTEROL SULFATE | REMEDYREPACK INC. | 0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda | 2026-04-13 | Warnings, Adverse reactions | ALBUTEROL SULFATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.