Application 204912
- Type
- ANDA
- Sponsor
- AKORN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION;OPHTHALMIC | 0.5% | No | No |
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 | Sandoz Inc | f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea | 2026-02-20 | 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 |