Application 207239

Type: ANDA
Sponsor: GLAND PHARMA 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 44.

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
A207239-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP		2017-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207239-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207239-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2017-02-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207239-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207239-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207239-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207239-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207239-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207239-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207239-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207239-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207239-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207239-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207239-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207239-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207239-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207239-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207239-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207239-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207239-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207239-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207239-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207239-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207239-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207239-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207239-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207239-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207239-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207239-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207239-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207239-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207239-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207239-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207239-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207239-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207239-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207239-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207239-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207239-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207239-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207239-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207239-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207239-001	AP	1	`3a93d1ddd44b…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
tranexamic acid	TRANEXAMIC ACID	Provepharm Inc.	1b8c3500-8e87-4b6e-b6a9-8da5f9c00820	2025-08-12	Warnings, Adverse reactions	Name fallback brand name: tranexamic acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Dr. Reddy's Laboratories Inc.	e5a52dad-e328-48f2-9182-4df46f5572ef	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Actavis Pharma, Inc.	3f07e93b-3568-487e-894f-8f90e5a0960a	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Amneal Pharmaceuticals Private Limited	615a9bec-f769-4774-8b05-22473b93668c	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
tranexamic acid in sodium chloride	TRANEXAMIC ACID	Avenacy Inc.	c3aad84a-aa99-42a0-b4b6-6fdee7585e19	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Proficient Rx LP	416cdb61-31fb-4554-835f-a7744aa33b61	2025-03-01	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Nexus Pharmaceuticals LLC	c479dccd-15c6-47c2-9675-680ebb9db2cb	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid in Sodium Chloride	TRANEXAMIC ACID	HP Halden Pharma AS	0c638812-ba60-49fe-a715-f40246b6cbf7	2025-01-14	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Caplin Steriles Limited	6326bdbf-fb2e-451a-a0a0-7d0b59ce5438	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Fresenius Kabi USA, LLC	63f6c65f-b06b-4905-8ff8-3ac87569c7e0	2024-11-15	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Emcure Pharmaceuticals Limited	ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a	2024-10-28		Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Bryant Ranch Prepack	af95be04-a6ea-4789-8e79-7dcad332c640	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Gland Pharma Limited	f06f07de-bedf-4b37-b15e-0959e0a154e6	2024-04-19	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
tranexamic acid	TRANEXAMIC ACID	Avenacy, Inc.	00630e54-0e84-465d-96a5-63486c87dcd9	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: tranexamic acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Armas Pharmaceuticals Inc.	a3468b9f-a1c1-43ca-afc0-5b32c8f58b83	2024-02-06	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	HF Acquisition Co LLC, DBA HealthFirst	c53e2b38-6c49-acae-e053-2995a90ae9df	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Bryant Ranch Prepack	128c39ce-f625-47ec-9efe-4de696e5220f	2024-01-15	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Aurobindo Pharma Limited	773eb919-7d48-4ba2-af58-aa169f0ea75f	2023-12-07	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Amneal Pharmaceuticals Private Limited	c1a38ece-2050-42ea-b9de-cae3e416c59d	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Bryant Ranch Prepack	4ddba10f-705a-40af-83b8-aa1fd68891f8	2023-11-06	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-601	Tranexamic Acid	tranexamic acid	Alvogen Inc.	ANDA	Current
47781-601	Tranexamic Acid	tranexamic acid	Alvogen Inc.	ANDA	Current
47781-601	Tranexamic Acid	tranexamic acid	Alvogen Inc.	ANDA	Current
68083-160	Tranexamic acid	Tranexamic acid	Gland Pharma Limited	ANDA	Current
68083-160	Tranexamic acid	Tranexamic acid	Gland Pharma Limited	ANDA	Current
68083-160	Tranexamic acid	Tranexamic acid	Gland Pharma Limited	ANDA	Current
68083-160	Tranexamic acid	Tranexamic acid	Gland Pharma Limited	ANDA	Current
70860-400	Tranexamic Acid	tranexamic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-400	Tranexamic Acid	tranexamic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-400	Tranexamic Acid	tranexamic acid	Athenex Pharmaceutical Division, LLC.	ANDA	Current
72611-760	Tranexamic Acid	tranexamic acid	Almaject, Inc.	ANDA	Current
72611-760	Tranexamic Acid	tranexamic acid	Almaject, Inc.	ANDA	Current