Application 216343
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.25% BASE | No | No |
| 002 | TIMOLOL MALEATE | TIMOLOL MALEATE | SOLUTION, GEL FORMING/DROPS;OPHTHALMIC | EQ 0.5% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216343-001 | TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | ||
| A216343-002 | TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 |
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 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | AB | 2024-05-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | AB | 2024-05-23 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216343-001 | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216343-002 | TIMOLOL MALEATE | EQ 0.5% BASE | SOLUTION, GEL FORMING/DROPS / OPHTHALMIC | 2024-05-23 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216343-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216343-002 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Timolol Maleate | TIMOLOL MALEATE | Rising Pharma Holdings, Inc. | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 2024-06-11 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| TIMOLOL MALEATE | TIMOLOL MALEATE | A-S Medication Solutions | 1ffd9ed1-8ab4-4036-bbc6-dcf58e659248 | 2024-06-03 | Warnings, Adverse reactions | TIMOLOL MALEATE TIMOLOL MALEATE |
| Timolol GFS | TIMOLOL MALEATE | Sandoz Inc | 72b0d0ec-832a-4c25-b845-2537ab506354 | 2024-05-28 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| TIMOLOL MALEATE | TIMOLOL MALEATE | Aurobindo Pharma Limited | e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2 | 2024-05-16 | Warnings, Adverse reactions | TIMOLOL MALEATE TIMOLOL MALEATE |
| TIMOLOL MALEATE | TIMOLOL MALEATE | Pacific Pharma, Inc. | e16c33fd-aa86-49ad-a767-c79ade4a62c7 | 2024-03-14 | Warnings, Adverse reactions | TIMOLOL MALEATE TIMOLOL MALEATE |
| timolol maleate | TIMOLOL MALEATE | First Nation Group, LLC | 140e1bfc-b75e-40d1-856c-242be4d9c8cc | 2024-03-07 | Warnings, Adverse reactions | timolol maleate TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Ingenus Pharmaceuticals, LLC | 4c4318b3-9865-4172-a7bd-9e68913eca1e | 2023-10-25 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
| timolol maleate | TIMOLOL MALEATE | Lifestar Pharma LLC | 545b7bee-8d5d-4206-b973-8de3c14d6dfe | 2023-07-03 | Warnings, Adverse reactions | timolol maleate TIMOLOL MALEATE |
| Timoptic | TIMOLOL MALEATE | Bausch & Lomb Incorporated | 45ac65b3-19f7-4f33-aebf-cadd3daa4bf1 | 2022-04-30 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| Timoptic-XE | TIMOLOL MALEATE | Bausch & Lomb Incorporated | a4d03de7-06b7-4cfc-9d1b-616969df209c | 2022-03-31 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| Timoptic in Ocudose | TIMOLOL MALEATE | Bausch & Lomb Incorporated | d130f0ec-c3b5-4bc3-8f4a-68fd6c3ec0cf | 2022-01-31 | Warnings, Adverse reactions | TIMOLOL MALEATE |
| Timolol Maleate | TIMOLOL MALEATE | Mylan Pharmaceuticals Inc. | 57c62928-63d8-4505-9b9e-c085a3a12c95 | 2020-07-06 | Warnings, Adverse reactions | Timolol Maleate TIMOLOL MALEATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78840 | ORIG | 2024-06-20 |