Application 021664
- Type
- NDA
- Sponsor
- BAUSCH AND LOMB INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XIBROM | BROMFENAC SODIUM | SOLUTION/DROPS;OPHTHALMIC | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | BROMDAY | BROMFENAC SODIUM | SOLUTION/DROPS;OPHTHALMIC | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N021664-001 | XIBROM | BROMFENAC SODIUM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | |
| N021664-002 | BROMDAY | BROMFENAC SODIUM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021664-001 | XIBROM | EQ 0.09% ACID | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021664-002 | BROMDAY | EQ 0.09% ACID | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021664-001 | XIBROM | EQ 0.09% ACID | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021664-002 | BROMDAY | EQ 0.09% ACID | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021664-001 | XIBROM | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2005-03-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021664-002 | BROMDAY | EQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 2010-10-16 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| Bromfenac Ophthalmic Solution, 0.07% | BROMFENAC SODIUM | Apotex Corp. | 4246c669-3c2a-2a2b-3b1c-696deb4ab519 | 2026-06-15 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| bromfenac ophthalmic solution | BROMFENAC SODIUM | Bausch & Lomb Americas Inc. | 246e2110-6a2d-4e22-8e37-72d80796b9af | 2026-05-05 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| Prolensa | BROMFENAC SODIUM | Bausch & Lomb Incorporated | 4e072537-f73c-4a96-a65f-e2805ce112d8 | 2026-05-05 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| bromfenac ophthalmic solution | BROMFENAC SODIUM | Dr. Reddy's Laboratories Inc. | fa249b9e-931c-454d-ba06-33139d5580e7 | 2026-05-05 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| BROMFENAC SODIUM | BROMFENAC SODIUM | Alembic Pharmaceuticals Inc. | f6911061-d00e-466d-b623-f81730f38f98 | 2025-04-07 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| bromfenac sodium | BROMFENAC SODIUM | Lupin Pharmaceuticals, Inc. | 26f3e5b3-a739-4b09-8046-e71ecb3a5a7b | 2025-03-27 | Warnings, Adverse reactions | BROMFENAC SODIUM |
| BROMFENAC SODIUM | BROMFENAC SODIUM | Alembic Pharmaceuticals Limited | f66f1436-daaa-412a-8822-c64866cfeada | 2024-07-09 | Warnings, Adverse reactions | BROMFENAC SODIUM |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-6301 | Bromday | bromfenac | Unit Dose Services | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 15945 | SUPPL | 2014-01-28 |
| 15944 | SUPPL | 2014-01-28 |
| 5948 | SUPPL | 2014-01-28 |
| 5947 | SUPPL | 2014-01-28 |
| 42261 | SUPPL | 2013-08-09 |
| 37425 | SUPPL | 2010-10-19 |
| 5946 | SUPPL | 2010-10-19 |
| 28334 | SUPPL | 2009-06-08 |
| 37424 | SUPPL | 2009-06-04 |
| 42260 | ORIG | 2007-06-29 |
| 28333 | SUPPL | 2006-01-30 |
| 15943 | SUPPL | 2006-01-27 |
| 28332 | ORIG | 2005-03-29 |
| 15942 | ORIG | 2005-03-29 |