Application 206066
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BEPOTASTINE BESILATE | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206066-001 | BEPOTASTINE BESILATE | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 |
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 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | 2019-03-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A206066-001 | BEPOTASTINE BESILATE | 1.5% | SOLUTION/DROPS / OPHTHALMIC | AT | 2019-03-05 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206066-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206066-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206066-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206066-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206066-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206066-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206066-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206066-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206066-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206066-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206066-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206066-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206066-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206066-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206066-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206066-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206066-001 | AT | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A206066-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206066-001 | AT | 1 | 782e0a99824c… |
| 2019-09-15 20:21 UTC | 2019-09 | A206066-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206066-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A206066-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A206066-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A206066-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A206066-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A206066-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206066-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A206066-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A206066-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A206066-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A206066-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A206066-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A206066-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A206066-001 | AT | 1 | 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 |
|---|---|---|---|---|---|---|
| Bepotastine Besilate | BEPOTASTINE BESILATE | Somerset Therapeutics, LLC | cd6a061d-8ad7-4ad1-b039-1e3aa3435d32 | 2024-10-10 | Warnings, Adverse reactions | Bepotastine Besilate BEPOTASTINE BESILATE |
| Bepotastine Besilate | BEPOTASTINE BESILATE | Bausch & Lomb Americas Inc. | 70430ab5-cd0a-451e-acab-347a2f981898 | 2024-08-20 | Warnings, Adverse reactions | Bepotastine Besilate BEPOTASTINE BESILATE |
| Bepreve | BEPOTASTINE BESILATE | Bausch & Lomb Incorporated | 68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6 | 2022-08-31 | Warnings, Adverse reactions | BEPOTASTINE BESILATE |
| Bepotastine Besilate | BEPOTASTINE BESILATE | Bausch & Lomb Incorporated | 995f4fe0-d861-4137-8090-a8ffc71c46f4 | 2020-12-31 | Warnings, Adverse reactions | Bepotastine Besilate BEPOTASTINE BESILATE |
| Bepotastine Besilate | BEPOTASTINE BESILATE | Mylan Pharmaceuticals Inc. | 75178670-aa57-45f9-94d5-efcf8305e683 | 2018-03-20 | Warnings, Adverse reactions | Bepotastine Besilate BEPOTASTINE BESILATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-6111 | Bepotastine Besilate | Bepotastine Besilate | Apotex Corp. | ANDA | Current |
| 60505-6111 | Bepotastine Besilate | Bepotastine Besilate | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58401 | ORIG | 2019-04-24 |