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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202755-001	TRANEXAMIC ACID	100MG/ML	INJECTABLE / INJECTION		2016-02-25	`cb3db0bc1861…`

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 1 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	Eugia US LLC	246a3c6c-a7fb-45c7-9509-49a48a5bdcc6	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Micro Labs Limited	ee5aeb09-40fb-40f9-b655-97c50652a05e	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	i3 Pharmaceuticals, LLC	2c48c13a-5e7d-43ef-81a3-27d3bcda0f80	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
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	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	NorthStar Rx LLC	4877eacd-fda7-4708-93a5-81052c1d2e14	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	4f42a81c-37e3-4b57-8e9a-d42c55bbfc52	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
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	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	American Health Packaging	cbc6f5b3-927e-4a94-8836-dbcd47ef97a8	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	AvPAK	e8cdb0d6-9498-2902-e053-2995a90a9de4	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	ADVAGEN PHARMA LIMITED	0a843fa7-1266-4666-b23f-22fd313d24a1	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Amneal Pharmaceuticals LLC	a4d95a17-9745-4780-b4dc-8683df8ca5bd	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Northstar Rx LLC	faa7c6bc-d7b9-48d5-9446-542a6a376db8	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	XGen Pharmaceuticals DJB, Inc.	1553f7eb-d5a8-4274-9762-5bcc5ffcf809	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Nordic Pharma, Inc.	031bf7c2-3b07-469d-bc5a-31fc6238e25f	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic acid	TRANEXAMIC ACID	Gland Pharma Limited	31462875-4941-4d50-bf0c-9675493731f3	2025-09-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tranexamic acid generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	REMEDYREPACK INC.	9d97790f-048b-494d-aa22-5689643a724b	2025-09-25	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
TRANEXAMIC ACID	TRANEXAMIC ACID	Bryant Ranch Prepack	5b0c13fe-2c8e-4ac8-8bda-140881bd0cc4	2025-09-24	Warnings, Adverse reactions	Name fallback brand name: TRANEXAMIC ACID generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Apotex Corp.	a93d6ef3-e160-db0d-142f-9b91af8d8428	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	Sagent Pharmaceuticals	b28a18a4-391d-48ab-8fa5-6391f15553f3	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID
Tranexamic Acid	TRANEXAMIC ACID	ANI Pharmaceuticals, Inc.	82bc4879-bcf5-47c4-8636-a73c4e7d0de9	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Tranexamic Acid generic name: TRANEXAMIC ACID

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