Application 202093

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANEXAMIC ACID	TRANEXAMIC ACID	TABLET;ORAL	650MG	No	No

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
A202093-001	TRANEXAMIC ACID	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB		2012-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202093-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202093-001	TRANEXAMIC ACID	650MG	TABLET / ORAL	AB	2012-12-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202093-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202093-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202093-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202093-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202093-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202093-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202093-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202093-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202093-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202093-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202093-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202093-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202093-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202093-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202093-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202093-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202093-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202093-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202093-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202093-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202093-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202093-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202093-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202093-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202093-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202093-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202093-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202093-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202093-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202093-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202093-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202093-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202093-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202093-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202093-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202093-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202093-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202093-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202093-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202093-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranexamic Acid	TRANEXAMIC ACID	Actavis Pharma, Inc.	3f07e93b-3568-487e-894f-8f90e5a0960a	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202093 application number: ANDA202093 ndc (product): 0591-3720
Tranexamic Acid	TRANEXAMIC ACID	Bryant Ranch Prepack	128c39ce-f625-47ec-9efe-4de696e5220f	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202093 application number: ANDA202093 ndc (product): 63629-8838
Tranexamic Acid	TRANEXAMIC ACID	Bryant Ranch Prepack	4ddba10f-705a-40af-83b8-aa1fd68891f8	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202093 application number: ANDA202093 ndc (product): 63629-8599

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3720	Tranexamic Acid	Tranexamic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-3720	Tranexamic Acid	Tranexamic Acid	Actavis Pharma, Inc.	ANDA	Current
0591-3720	Tranexamic Acid	Tranexamic Acid	Actavis Pharma, Inc.	ANDA	Current
63629-8599	Tranexamic Acid	Tranexamic Acid	Bryant Ranch Prepack	ANDA	Current
63629-8838	Tranexamic Acid	Tranexamic Acid	Bryant Ranch Prepack	ANDA	Current
63629-8838	Tranexamic Acid	Tranexamic Acid	Bryant Ranch Prepack	ANDA	Current
68084-929	Tranexamic Acid	Tranexamic Acid	American Health Packaging	ANDA	Current
68084-929	Tranexamic Acid	Tranexamic Acid	American Health Packaging	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45793	ORIG	2016-11-02
32173	ORIG	2012-12-28
9957	ORIG	2012-05-24