Home Applications 022430 Application 022430
Type NDA
Sponsor FERRING PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYSTEDA TRANEXAMIC ACID TABLET;ORAL 650MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table 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# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table 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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-09-29 23:25 UTC 2022-09 N022430-001 LYSTEDA 650MG TABLET / ORAL AB RLD, RS 2009-11-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 8 · 312 observed states.
Captured, Edition, Application-product table 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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table 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 table 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