FDA.reportPublic FDA data

Application 219123

Type
ANDA
Sponsor
BIONPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDTABLET;ORAL650MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219123-001TRANEXAMIC ACIDTRANEXAMIC ACID650MGTABLET / ORAL2025-08-19

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219123-001TRANEXAMIC ACID650MGTABLET / ORALAB2025-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219123-001TRANEXAMIC ACID650MGTABLET / ORALAB2025-08-1931067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219123-001TRANEXAMIC ACID650MGTABLET / ORAL2025-08-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219123-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219123-001AB131067a03dcf5…

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 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tranexamic AcidTRANEXAMIC ACIDEugia US LLC246a3c6c-a7fb-45c7-9509-49a48a5bdcc62026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDMicro Labs Limitedee5aeb09-40fb-40f9-b655-97c50652a05e2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDi3 Pharmaceuticals, LLC2c48c13a-5e7d-43ef-81a3-27d3bcda0f802026-06-29Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.28ccedba-99cd-49f3-a782-798df52585242026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4f42a81c-37e3-4b57-8e9a-d42c55bbfc522026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.d5f55a98-aeb8-47e1-9154-87ba702220272026-04-10Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDAmerican Health Packagingcbc6f5b3-927e-4a94-8836-dbcd47ef97a82026-03-03Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDAvPAKe8cdb0d6-9498-2902-e053-2995a90a9de42026-01-12Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDADVAGEN PHARMA LIMITED0a843fa7-1266-4666-b23f-22fd313d24a12026-01-07Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDAmneal Pharmaceuticals LLCa4d95a17-9745-4780-b4dc-8683df8ca5bd2025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDNorthstar Rx LLCfaa7c6bc-d7b9-48d5-9446-542a6a376db82025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDXGen Pharmaceuticals DJB, Inc.1553f7eb-d5a8-4274-9762-5bcc5ffcf8092025-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDNordic Pharma, Inc.031bf7c2-3b07-469d-bc5a-31fc6238e25f2025-09-29Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic acidTRANEXAMIC ACIDGland Pharma Limited31462875-4941-4d50-bf0c-9675493731f32025-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDREMEDYREPACK INC.9d97790f-048b-494d-aa22-5689643a724b2025-09-25Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDBryant Ranch Prepack5b0c13fe-2c8e-4ac8-8bda-140881bd0cc42025-09-24Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDApotex Corp.a93d6ef3-e160-db0d-142f-9b91af8d84282025-09-22Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDSagent Pharmaceuticalsb28a18a4-391d-48ab-8fa5-6391f15553f32025-09-19Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDANI Pharmaceuticals, Inc.82bc4879-bcf5-47c4-8636-a73c4e7d0de92025-09-19Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDMylan Institutional LLC6f033f1e-8c78-4c87-b870-6493944315ff2025-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID