Application 202755

Type: ANDA
Sponsor: VIRTUS PHARMS

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 43.

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
A202755-001	TRANEXAMIC ACID	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION			2016-02-25

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 · 43 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
2026-09-14 22:38:34	2026-08	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2016-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2016-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2016-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION	AP	2016-02-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202755-001	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A202755-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202755-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202755-001	AP	1	`ea99ee380514…`

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 3 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
TRANEXAMIC ACID	TRANEXAMIC ACID	Armas Pharmaceuticals Inc.	8d732fca-8157-49f9-9f08-acf9afb75aa2	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Sagent Pharmaceuticals	0277db2d-7c81-4cd0-ac19-fa12b5721428	2023-06-20	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Baxter Healthcare Corporation	32750a05-6617-46e8-b9e7-04e613e6bf4b	2021-02-26	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDE	TRANEXAMIC ACID	Exela Pharma Sciences, LLC	db36ddf2-4ac5-47ac-bdce-e3fa6983073e	2019-04-22	Warnings, Adverse reactions	Name fallback 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69543-376	Tranexamic Acid	Tranexamic Acid	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-376	Tranexamic Acid	Tranexamic Acid	Virtus Pharmaceuticals, LLC	ANDA	Current
69543-376	Tranexamic Acid	Tranexamic Acid	Virtus Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10100	ORIG	2016-03-02