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Active ingredient

Tranexamic Acid

52 finished FDA listings contain Tranexamic Acid as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TRANEXAMIC ACID
Dosage forms
Injection, Injection, Solution, Tablet, Tablet, Film Coated
Routes
Intravenous, Oral
Manufacturers / labelers
39
Strengths listed
1 g/10ml · 10 mg/ml · 100 mg/ml · 650 mg/1
Brand names in FDA listings
Cyklokapron, Tranexamic Acid In Sodium Chloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10691

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019281PFIZER1986-12-301
NDA 022430J MOLNER2009-11-132
ANDA 091657MYLAN INSTITUTIONAL2011-11-031
ANDA 202093ACTAVIS LABS FL INC2012-12-273
ANDA 201580PHARMOBEDIENT2013-06-141
ANDA 202436HERITAGE2014-02-112
ANDA 203521AVET LIFESCIENCES2014-08-125
ANDA 205133AUROBINDO PHARMA USA2015-09-212
ANDA 205035EUGIA PHARMA2016-01-142
ANDA 203256ANI PHARMS2016-07-253
ANDA 207239GLAND2017-02-133
ANDA 208840AMNEAL PHARMS CO2017-02-281
ANDA 206713MICRO LABS2017-06-273
NDA 212020EXELA PHARMA2019-04-151
ANDA 212360CAPLIN2019-07-174
ANDA 212676MILLA PHARMS2019-07-174
ANDA 209860APOTEX2020-01-141
ANDA 217155AMNEAL2023-10-162
ANDA 218599GLAND2024-04-162
ANDA 216877NEXUS2024-04-161
ANDA 218320RUBICON RESEARCH2024-06-113
ANDA 218242FRESENIUS KABI USA2024-08-152
ANDA 218896HERITAGE2025-06-021
ANDA 218729APPCO2025-06-111
ANDA 219702PHARMAZONE2026-01-261

Official labeling on DailyMed

Showing the 12 most recent of 47 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.