Application 020613
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALPHAGAN | BRIMONIDINE TARTRATE | SOLUTION/DROPS;OPHTHALMIC | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020613-001 | ALPHAGAN | BRIMONIDINE TARTRATE | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 |
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| 2026-08 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020613-001 | ALPHAGAN | 0.2% | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020613-001 | ALPHAGAN | 0.2% | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020613-001 | ALPHAGAN | 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1996-09-06 | 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 |
|---|---|---|---|---|---|---|
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Apotex Corp. | e08a915a-77ca-4d16-d760-11b05848418d | 2026-09-09 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| brimonidine tartrate | BRIMONIDINE TARTRATE | Micro Labs Limited | 981a75cd-2487-40e4-911a-26de2aa98dc1 | 2026-05-21 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| LUMIFY Redness Reliever Eye Drops | BRIMONIDINE TARTRATE | Bausch & Lomb Incorporated | 022de945-0b26-40ae-8e88-d3fe2464d106 | 2026-03-31 | Warnings | BRIMONIDINE TARTRATE |
| LUMIFY PRESERVATIVE FREE EYE DROPS | BRIMONIDINE TARTRATE | Bausch & Lomb Incorporated | ef5974b9-946c-4983-80e3-32b3aa28c207 | 2026-03-17 | Warnings | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Gland Pharma Limited | e4b04ef1-6586-4386-a844-2c5fc3bd4a8f | 2026-03-12 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Florida Pharmaceutical Products, LLC | a25f7abf-e066-4d16-a0ba-6150bdace81d | 2026-01-28 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Upsher-Smith Laboratories, LLC | 5a634ed6-f00a-472e-93c9-8dcd496997a2 | 2025-12-15 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Sandoz Inc | b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd | 2025-11-24 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Apotex Corp. | 64b21e68-610c-5194-ccb2-9d9f6ff8cda9 | 2025-10-08 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine | BRIMONIDINE TARTRATE | Sandoz Inc | 87c5a534-4321-46c7-9938-84dca34b6506 | 2025-10-07 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine tartrate | BRIMONIDINE TARTRATE | Pacific Pharma, Inc. | 5c4aea88-95ca-4da8-a3da-02f10c8b6623 | 2025-09-18 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| ALPHAGAN P | BRIMONIDINE TARTRATE | Allergan, Inc. | 264c4494-c225-486f-888a-caaf36be46b3 | 2025-09-18 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine tartrate | BRIMONIDINE TARTRATE | Micro Labs Limited | 75c5f708-1afb-4505-94a6-a2c0afb0aedc | 2025-07-24 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Sandoz Inc | dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde | 2025-05-30 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | Somerset Therapeutics, LLC | cdb8620f-adfa-4433-b285-9c42334f8600 | 2025-03-22 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Mirvaso | BRIMONIDINE TARTRATE | Galderma Laboratories, L.P. | f6a4353f-ae69-4214-901f-e5d42a6fbde7 | 2024-10-24 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| BRIMONIDINE TARTRATE | BRIMONIDINE TARTRATE | Somerset Therapeutics, LLC | b8e108b3-aca8-4e3e-8577-37ac796148c3 | 2024-08-26 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Bausch & Lomb Incorporated | 865f88b0-b13e-4607-a314-939f1b331e6f | 2024-07-19 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Alembic Pharmaceuticals Limited | ee26e0c9-a169-4842-ab0f-3c718bb14018 | 2023-08-28 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
| Brimonidine Tartrate | BRIMONIDINE TARTRATE | Alembic Pharmaceuticals Inc. | 9da815fb-6454-4925-9150-bec40eff9c2d | 2023-08-11 | Warnings, Adverse reactions | BRIMONIDINE TARTRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.