Application 212360

Type: ANDA
Sponsor: CAPLIN

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
A212360-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2019-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212360-001	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.

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	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2019-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2019-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2019-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2019-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212360-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2019-07-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212360-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212360-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212360-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212360-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212360-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212360-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212360-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212360-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212360-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212360-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212360-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212360-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212360-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212360-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212360-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212360-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212360-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212360-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212360-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212360-001	AP	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A212360-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212360-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212360-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212360-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212360-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212360-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212360-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212360-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212360-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212360-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212360-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212360-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212360-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212360-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212360-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212360-001	AP	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRANEXAMIC ACID	TRANEXAMIC ACID	REMEDYREPACK INC.	9d97790f-048b-494d-aa22-5689643a724b	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212360 application number: ANDA212360
Tranexamic Acid	TRANEXAMIC ACID	Caplin Steriles Limited	6326bdbf-fb2e-451a-a0a0-7d0b59ce5438	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212360 application number: ANDA212360 ndc (product): 65145-106
Tranexamic Acid	TRANEXAMIC ACID	Armas Pharmaceuticals Inc.	a3468b9f-a1c1-43ca-afc0-5b32c8f58b83	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212360 application number: ANDA212360
TRANEXAMIC ACID	TRANEXAMIC ACID	Baxter Healthcare Corporation	32750a05-6617-46e8-b9e7-04e613e6bf4b	2021-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212360 application number: ANDA212360 ndc (product): 43066-008

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
43066-008	TRANEXAMIC ACID	tranexamic acid	Baxter Healthcare Corporation	ANDA	Current
43066-008	TRANEXAMIC ACID	tranexamic acid	Baxter Healthcare Corporation	ANDA	Current
43066-008	TRANEXAMIC ACID	tranexamic acid	Baxter Healthcare Corporation	ANDA	Current
43066-008	TRANEXAMIC ACID	tranexamic acid	Baxter Healthcare Corporation	ANDA	Current
43066-008	TRANEXAMIC ACID	tranexamic acid	Baxter Healthcare Corporation	ANDA	Current
65145-106	Tranexamic Acid	Tranexamic Acid	Caplin Steriles Limited	ANDA	Current
65145-106	Tranexamic Acid	Tranexamic Acid	Caplin Steriles Limited	ANDA	Current
65145-106	Tranexamic Acid	Tranexamic Acid	Caplin Steriles Limited	ANDA	Current