Application 072467
- Type
- ANDA
- Sponsor
- QUANTUM PHARMICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMOLOL MALEATE | TIMOLOL MALEATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072467-001 | TIMOLOL MALEATE | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 |
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 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A072467-001 | TIMOLOL MALEATE | 10MG | TABLET / ORAL | 1989-05-19 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Timoptic in Ocudose | TIMOLOL MALEATE | Nordic Pharma, Inc. | 16323b0e-78ae-40e5-be93-04f698dd672b | 2026-05-22 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Oceanside Pharmaceuticals | 3c20b537-88c6-4ec7-a359-e0ba67afe431 | 2026-04-20 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Sagent Pharmaceuticals | 272bb565-f099-4896-b2f6-48ab9180e941 | 2026-01-09 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | A-S Medication Solutions | 7a1ea848-5b55-4038-afb1-029645ee0925 | 2025-12-30 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol maleate | TIMOLOL MALEATE | Armas Pharmaceuticals, Inc. | ea585fe8-3356-4f08-8078-34e8ab5de37e | 2025-12-03 | Warnings, Adverse reactions | Timolol maleate TIMOLOL MALEATE |
| TIMOLOL MALEATE | TIMOLOL MALEATE | Rising Pharma Holdings, Inc. | 2ed21930-1e05-46de-8acd-cb6f4798a7fa | 2025-05-09 | Warnings, Adverse reactions | TIMOLOL MALEATE TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Bausch & Lomb Americas Inc. | 581f80f7-4419-49e2-867d-40443c75409f | 2025-03-26 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Bausch & Lomb Americas Inc. | 036dc753-1698-4c69-9bcf-752c7061203c | 2025-03-05 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Bausch & Lomb Americas Inc. | 9c14ca2d-80f3-48ef-b99a-beafaa728a24 | 2025-03-04 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | A-S Medication Solutions | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 | 2024-12-20 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Micro Labs Limited | 79b223e4-d929-4667-8149-e79bfab13fdf | 2024-12-05 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Bausch & Lomb Americas Inc. | b686bbad-1ef7-4b94-a316-4d182a40b89a | 2024-11-04 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Somerset Therapeutics, LLC | e797f7c7-0588-4627-b060-8df6bcfe3f7b | 2024-10-31 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Istalol | TIMOLOL MALEATE | Bausch & Lomb Incorporated | 258bbc8d-00ee-45b0-ac35-6f16c4e8d45f | 2024-10-30 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| TIMOLOL MALEATE | TIMOLOL MALEATE | Leading Pharma, LLC | d6fa2971-dacf-42ab-99bc-c7ce6013221e | 2024-10-30 | Warnings, Adverse reactions | TIMOLOL MALEATE TIMOLOL MALEATE |
| timolol maleate | TIMOLOL MALEATE | NorthStar RxLLC | 9db7322d-eb31-4fff-9b14-8a0294d01704 | 2024-10-14 | Warnings, Adverse reactions | timolol maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE OPHTHALMIC | Micro Labs Limited | 6c9f3971-8c07-4d3a-915d-76438baa2a0b | 2024-10-03 | Warnings, Adverse reactions | Timolol Maleate |
| Timolol Maleate | TIMOLOL MALEATE | Caplin Steriles Limited | 4847f180-45e6-40f0-ae8c-6cc500cb0add | 2024-08-19 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| Timolol maleate | TIMOLOL MALEATE | Somerset Therapeutics, LLC | 5d60db57-ca24-4cab-a90d-8cf06992a34e | 2024-07-04 | Warnings, Adverse reactions | Timolol maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Rising Pharma Holdings, Inc. | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 2024-06-11 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |