Application 203521

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANEXAMIC ACID	TRANEXAMIC ACID	INJECTABLE;INJECTION	100MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203521-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2014-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203521-001	AP

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203521-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2014-08-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203521-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203521-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203521-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203521-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203521-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203521-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203521-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203521-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203521-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203521-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203521-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203521-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203521-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203521-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203521-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203521-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203521-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203521-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203521-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203521-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203521-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203521-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203521-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203521-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203521-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203521-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203521-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203521-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203521-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203521-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203521-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203521-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203521-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203521-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203521-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203521-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203521-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203521-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203521-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203521-001	AP	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.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tranexamic Acid	TRANEXAMIC ACID	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	28ccedba-99cd-49f3-a782-798df5258524	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521 ndc (product): 23155-166
Tranexamic Acid	TRANEXAMIC ACID	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	d5f55a98-aeb8-47e1-9154-87ba70222027	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521 ndc (product): 23155-524
TRANEXAMIC ACID	TRANEXAMIC ACID	Northstar Rx LLC	faa7c6bc-d7b9-48d5-9446-542a6a376db8	2025-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521
Tranexamic Acid	TRANEXAMIC ACID	Emcure Pharmaceuticals Limited	ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a	2024-10-28		Exact identifier application applno (ANDA): 203521 application number: ANDA203521
tranexamic acid	TRANEXAMIC ACID	Avenacy, Inc.	00630e54-0e84-465d-96a5-63486c87dcd9	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203521 application number: ANDA203521

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-166	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-524	Tranexamic Acid	Tranexamic Acid	Heritage Pharmaceuticals Inc.	ANDA	Current
70860-407	Tranexamic Acid	tranexamic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current