Application 212020

Type: NDA
Sponsor: EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANEXAMIC ACID	TRANEXAMIC ACID	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	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
N212020-001	TRANEXAMIC ACID	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N212020-001	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 · 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	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2019-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212020-001	TRANEXAMIC ACID	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-04-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N212020-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212020-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212020-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212020-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212020-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212020-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212020-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212020-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212020-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212020-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212020-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212020-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212020-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212020-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212020-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212020-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212020-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212020-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212020-001	AP	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212020-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Exela Pharma Sciences, LLC	db36ddf2-4ac5-47ac-bdce-e3fa6983073e	2019-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212020 application number: NDA212020 ndc (product): 51754-0108

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51754-0108	TRANEXAMIC ACID IN SODIUM CHLORIDE	tranexamic acid	Exela Pharma Sciences, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63970	SUPPL	2020-07-20
63946	SUPPL	2020-07-17
60748	ORIG	2019-10-31
58385	ORIG	2019-04-24
58361	ORIG	2019-04-19