Tranexamic Acid Injectable Solution

Brand(s)
Cyklokapron
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-03-16)
Oldest Current Product
1986-12-30
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\TRANEXAMIC ACID
FDAOB
INJECTION\INJECTION\TRANEXAMIC ACID\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\TRANEXAMIC ACID
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\TRANEXAMIC ACID

product(s) by strength(s)

tranexamic acid 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000131114CyklokapronNDAPharmacia And Upjohn Company1986-12-30TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONNDA0192816e89a7d9-4da4-42aa-b7f8-c602c24eefe5

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170960ANDAAmerican Regent, Inc.2011-11-15TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA20188581916afc-f83a-4bba-a810-17393980e27e
2147890500ANDANexus Pharmaceuticals Inc2012-03-15TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA091596dbfb0fdd-e5cc-4d54-a998-3b8fd63ed45c
3174780217ANDAAkorn2015-03-09TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA202373cdf34cb8-e02b-402a-805b-51ae29e7320c
4231550166ANDAHeritage Pharmaceuticals Inc.2012-02-20TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA20352128ccedba-99cd-49f3-a782-798df5258524
5231550524ANDAHeritage Pharmaceuticals Inc.2014-08-13TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA203521d5f55a98-aeb8-47e1-9154-87ba70222027
6398221000ANDAX-Gen Pharmaceuticals, Inc.2012-05-18TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA2015801553f7eb-d5a8-4274-9762-5bcc5ffcf809
7398221001ANDAX-Gen Pharmaceuticals, Inc.2012-05-18TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA201580e6abc22f-4fac-4e7e-98e6-8f25b0f04420
8421920605ANDAAcella Pharmaceuticals, Llc2014-02-11TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA202436e8a45862-2187-49eb-892e-ade1b0cde938
9633230563ANDAApp Pharmaceuticals, Llc2012-04-20, 2012-05-24TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA091596, ANDA202373c6c3da51-fc45-4d5c-b983-1576830c95dd, ce8c554a-0875-40cb-b3dd-3e34c0ae6a87
10674570197ANDAMylan Institutional Llc2011-11-29TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA0916576f033f1e-8c78-4c87-b870-6493944315ff
11674570293ANDAMylan Institutional Llc2011-11-29TRANEXAMIC ACIDINTRAVENOUSINJECTION, SOLUTIONANDA0916576f033f1e-8c78-4c87-b870-6493944315ff

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA091596TRANEXAMIC ACIDFRESENIUS KABI USA LLC2012-03-02ANDA091596_001
2ANDA091657TRANEXAMIC ACIDMYLAN INSTITUTIONAL LLC2011-11-03ANDA091657_001
3ANDA201580TRANEXAMIC ACIDX-GEN PHARMACEUTICALS INC2013-06-14ANDA201580_001
4ANDA201885TRANEXAMIC ACIDLUITPOLD PHARMACEUTICALS INC2011-08-10ANDA201885_001
5ANDA202373TRANEXAMIC ACIDVERSAPHARM INCORPORATED2011-11-17ANDA202373_001
6ANDA202436TRANEXAMIC ACIDACIC FINE CHEMICALS INC2014-02-11ANDA202436_001
7ANDA203521TRANEXAMIC ACIDEMCURE PHARMACEUTICALS LTD2014-08-12ANDA203521_001
8NDA019281CYKLOKAPRONPHARMACIA AND UPJOHN CO1986-12-30NDA019281_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA091596_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2012-03-02TRANEXAMIC ACID
2ANDA091657_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2011-11-03TRANEXAMIC ACID
3ANDA201580_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2013-06-14TRANEXAMIC ACID
4ANDA201885_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2011-08-10TRANEXAMIC ACID
5ANDA202373_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2011-11-17TRANEXAMIC ACID
6ANDA202436_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2014-02-11TRANEXAMIC ACID
7ANDA203521_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONFalseAP2014-08-12TRANEXAMIC ACID
8NDA019281_001RXTRANEXAMIC ACID (100MG/ML)INJECTIONTrueAP1986-12-30CYKLOKAPRON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11553f7eb-d5a8-4274-9762-5bcc5ffcf809 (view SPL)Tranexamic Acid InjectionprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2013-08-132398221000
228ccedba-99cd-49f3-a782-798df5258524 (view SPL)Antifibrinolytic agentprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-203231550166
36e89a7d9-4da4-42aa-b7f8-c602c24eefe5 (view SPL)CYKLOKAPRON tranexamic acid injectionprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-03-1613000131114
46f033f1e-8c78-4c87-b870-6493944315ff (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-05-258674570197, 674570293
581916afc-f83a-4bba-a810-17393980e27e (view SPL)TRANEXAMIC ACID INJECTIONprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2014-01-117005170960
6c6c3da51-fc45-4d5c-b983-1576830c95dd (view SPL)Tranexamic Acid InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-233633230563
7cdf34cb8-e02b-402a-805b-51ae29e7320c (view SPL)prescriptionHuman PrescriptionAkorn2015-03-092174780217
8ce8c554a-0875-40cb-b3dd-3e34c0ae6a87 (view SPL)TRANEXAMIC ACID INJECTIONprescriptionHuman PrescriptionApp Pharmaceuticals, Llc2014-10-272633230563
9d5f55a98-aeb8-47e1-9154-87ba70222027 (view SPL)Antifibrinolytic agentprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-07-091231550524
10dbfb0fdd-e5cc-4d54-a998-3b8fd63ed45c (view SPL)prescriptionHuman PrescriptionNexus Pharmaceuticals IncMANUFACTURE2012-03-131147890500
11e6abc22f-4fac-4e7e-98e6-8f25b0f04420 (view SPL)Tranexamic Acid InjectionprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-06-061398221001
12e8a45862-2187-49eb-892e-ade1b0cde938 (view SPL)prescriptionHuman PrescriptionAcella Pharmaceuticals, Llc2014-02-201421920605

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII