Application 022430
- Type
- NDA
- Sponsor
- FERRING PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LYSTEDA | TRANEXAMIC ACID | TABLET;ORAL | 650MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022430-001 | LYSTEDA | TRANEXAMIC ACID | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022430-001 | AB |
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 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022430-001 | LYSTEDA | 650MG | TABLET / ORAL | AB | RLD, RS | 2009-11-13 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022430-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022430-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022430-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022430-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022430-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022430-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022430-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022430-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022430-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022430-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022430-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022430-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022430-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022430-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022430-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022430-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022430-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022430-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022430-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022430-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022430-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022430-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022430-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022430-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022430-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022430-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022430-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022430-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022430-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022430-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022430-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022430-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022430-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022430-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022430-001 | AB | 1 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 7947739 | 2025-03-04 | Drug product | 2011-05-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8022106 | 2025-03-04 | U-1182 | 2011-09-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8273795 | 2025-03-04 | U-1182 | 2012-09-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8487005 | 2025-03-04 | U-1182 | Drug product | 2013-07-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8791160 | 2025-03-04 | U-1182 | Drug product | 2014-08-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8809394 | 2025-03-04 | U-1182 | Drug product | 2014-09-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 8957113 | 2025-03-04 | U-1182 | Drug product | 2015-02-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022430-001 | 9060939 | 2025-03-04 | Drug product | 2015-06-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 7947739 | 2025-03-04 | Drug product | 2011-05-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8022106 | 2025-03-04 | U-1182 | 2011-09-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8273795 | 2025-03-04 | U-1182 | 2012-09-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8487005 | 2025-03-04 | U-1182 | Drug product | 2013-07-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8791160 | 2025-03-04 | U-1182 | Drug product | 2014-08-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8809394 | 2025-03-04 | U-1182 | Drug product | 2014-09-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 8957113 | 2025-03-04 | U-1182 | Drug product | 2015-02-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022430-001 | 9060939 | 2025-03-04 | Drug product | 2015-06-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 7947739 | 2025-03-04 | Drug product | 2011-05-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8022106 | 2025-03-04 | U-1182 | 2011-09-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8273795 | 2025-03-04 | U-1182 | 2012-09-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8487005 | 2025-03-04 | U-1182 | Drug product | 2013-07-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8791160 | 2025-03-04 | U-1182 | Drug product | 2014-08-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8809394 | 2025-03-04 | U-1182 | Drug product | 2014-09-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 8957113 | 2025-03-04 | U-1182 | Drug product | 2015-02-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022430-001 | 9060939 | 2025-03-04 | Drug product | 2015-06-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 7947739 | 2025-03-04 | Drug product | 2011-05-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8022106 | 2025-03-04 | U-1182 | 2011-09-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8273795 | 2025-03-04 | U-1182 | 2012-09-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8487005 | 2025-03-04 | U-1182 | Drug product | 2013-07-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8791160 | 2025-03-04 | U-1182 | Drug product | 2014-08-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8809394 | 2025-03-04 | U-1182 | Drug product | 2014-09-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 8957113 | 2025-03-04 | U-1182 | Drug product | 2015-02-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022430-001 | 9060939 | 2025-03-04 | Drug product | 2015-06-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 7947739 | 2025-03-04 | Drug product | 2011-05-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8022106 | 2025-03-04 | U-1182 | 2011-09-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8273795 | 2025-03-04 | U-1182 | 2012-09-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8487005 | 2025-03-04 | U-1182 | Drug product | 2013-07-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8791160 | 2025-03-04 | U-1182 | Drug product | 2014-08-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8809394 | 2025-03-04 | U-1182 | Drug product | 2014-09-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 8957113 | 2025-03-04 | U-1182 | Drug product | 2015-02-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022430-001 | 9060939 | 2025-03-04 | Drug product | 2015-06-23 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| Tranexamic Acid | TRANEXAMIC ACID | AvPAK | e8cdb0d6-9498-2902-e053-2995a90a9de4 | 2026-01-12 | Warnings, Adverse reactions | 022430 NDA022430 50268-772 |
| Tranexamic Acid | TRANEXAMIC ACID | Nordic Pharma, Inc. | 031bf7c2-3b07-469d-bc5a-31fc6238e25f | 2025-09-29 | Warnings, Adverse reactions | 022430 NDA022430 69918-301 |
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 |
|---|---|---|---|---|---|
| 50268-772 | Tranexamic Acid | Tranexamic Acid | AvPAK | NDA AUTHORIZED GENERIC | Current |
| 55566-2110 | Lysteda | Tranexamic Acid | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2110 | Lysteda | Tranexamic Acid | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2110 | Lysteda | Tranexamic Acid | Ferring Pharmaceuticals Inc. | NDA | Current |
| 55566-2110 | Lysteda | Tranexamic Acid | Ferring Pharmaceuticals Inc. | NDA | Current |
| 66993-090 | Tranexamic Acid | Tranexamic Acid | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-121 | Tranexamic Acid | Tranexamic Acid | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 69918-300 | Lysteda | Tranexamic Acid | Amring Pharmaceuticals Inc. | NDA | Current |
| 69918-300 | Lysteda | Tranexamic Acid | Amring Pharmaceuticals Inc. | NDA | Current |
| 69918-301 | Tranexamic Acid | Tranexamic Acid | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-301 | Tranexamic Acid | Tranexamic Acid | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-301 | Tranexamic Acid | Tranexamic Acid | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-301 | Tranexamic Acid | Tranexamic Acid | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 69918-301 | Tranexamic Acid | Tranexamic Acid | Amring Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 71335-1957 | Tranexamic Acid | Tranexamic Acid | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
| 71335-1957 | Tranexamic Acid | Tranexamic Acid | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65569 | SUPPL | 2020-12-10 |
| 65537 | SUPPL | 2020-12-09 |
| 38705 | SUPPL | 2013-10-08 |
| 29726 | SUPPL | 2013-10-04 |
| 17584 | SUPPL | 2013-08-22 |
| 7388 | SUPPL | 2013-08-22 |
| 42523 | SUPPL | 2011-10-10 |
| 7387 | SUPPL | 2011-04-11 |
| 17583 | SUPPL | 2011-04-07 |
| 42522 | ORIG | 2010-05-06 |
| 24306 | ORIG | 2010-05-06 |
| 7386 | ORIG | 2009-11-19 |
| 38704 | ORIG | 2009-11-17 |
| 51496 | ORIG | 1900-01-01 |