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 43.

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
2026-09-14 22:38:342026-08A219123-001TRANEXAMIC ACID650MGTABLET / ORAL2025-08-1984e616aacf4f…
2026-08-18 06:07:402026-07A219123-001TRANEXAMIC ACID650MGTABLET / ORAL2025-08-19caaa826d4ba7…
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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CyklokapronTRANEXAMIC ACIDPfizer Laboratories Div Pfizer Inc6e89a7d9-4da4-42aa-b7f8-c602c24eefe52025-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
tranexamic acidTRANEXAMIC ACIDProvepharm Inc.1b8c3500-8e87-4b6e-b6a9-8da5f9c008202025-08-12Warnings, Adverse reactionsName fallback
brand name: tranexamic acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDDr. Reddy's Laboratories Inc.e5a52dad-e328-48f2-9182-4df46f5572ef2025-08-01Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDActavis Pharma, Inc.3f07e93b-3568-487e-894f-8f90e5a0960a2025-07-15Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDAmneal Pharmaceuticals Private Limited615a9bec-f769-4774-8b05-22473b93668c2025-05-30Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
tranexamic acid in sodium chlorideTRANEXAMIC ACIDAvenacy Inc.c3aad84a-aa99-42a0-b4b6-6fdee7585e192025-03-28Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDProficient Rx LP416cdb61-31fb-4554-835f-a7744aa33b612025-03-01Warnings, Adverse reactionsName fallback
brand name: TRANEXAMIC ACID
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDNexus Pharmaceuticals LLCc479dccd-15c6-47c2-9675-680ebb9db2cb2025-02-26Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic Acid in Sodium ChlorideTRANEXAMIC ACIDHP Halden Pharma AS0c638812-ba60-49fe-a715-f40246b6cbf72025-01-14Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDCaplin Steriles Limited6326bdbf-fb2e-451a-a0a0-7d0b59ce54382025-01-03Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDFresenius Kabi USA, LLC63f6c65f-b06b-4905-8ff8-3ac87569c7e02024-11-15Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDEmcure Pharmaceuticals Limitedceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a2024-10-28Name fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDSagent Pharmaceuticals80465b90-3f92-4e35-b2ba-69871bbd4a7f2024-08-14Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDBryant Ranch Prepackaf95be04-a6ea-4789-8e79-7dcad332c6402024-08-08Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACID IN SODIUM CHLORIDETRANEXAMIC ACIDGland Pharma Limitedf06f07de-bedf-4b37-b15e-0959e0a154e62024-04-19Warnings, Adverse reactionsName fallback
generic name: TRANEXAMIC ACID
tranexamic acidTRANEXAMIC ACIDAvenacy, Inc.00630e54-0e84-465d-96a5-63486c87dcd92024-03-15Warnings, Adverse reactionsName fallback
brand name: tranexamic acid
generic name: TRANEXAMIC ACID
Tranexamic AcidTRANEXAMIC ACIDArmas Pharmaceuticals Inc.a3468b9f-a1c1-43ca-afc0-5b32c8f58b832024-02-06Warnings, Adverse reactionsName fallback
brand name: Tranexamic Acid
generic name: TRANEXAMIC ACID
TRANEXAMIC ACIDTRANEXAMIC ACIDHF Acquisition Co LLC, DBA HealthFirstc53e2b38-6c49-acae-e053-2995a90ae9df2024-01-30Warnings, Adverse reactionsName 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.