Tranexamic Acid Oral Tablet

Brand(s)
Lysteda
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ferring Pharmaceuticals Inc. (2011-04-01)
Oldest Current Product
2010-05-17
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TRANEXAMIC ACID
FDAOB
ORAL\TABLET\TRANEXAMIC ACID
SPL Active
ORAL\TABLET, FILM COATED\TRANEXAMIC ACID
ORAL\TABLET\TRANEXAMIC ACID
SPL Moiety
ORAL\TABLET, FILM COATED\TRANEXAMIC ACID
ORAL\TABLET\TRANEXAMIC ACID

product(s) by strength(s)

tranexamic acid 650 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1555662100LystedaNDAFerring Pharmaceuticals Inc.2010-05-17TRANEXAMIC ACIDORALTABLETNDA02243084a65305-65d7-e7fd-66f3-dda8d8f920b1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913720ANDAWatson Laboratories, Inc.2013-01-03TRANEXAMIC ACIDORALTABLET, FILM COATEDANDA2020933f07e93b-3568-487e-894f-8f90e5a0960a
2605053638ANDAApotex Corp2014-01-27TRANEXAMIC ACIDORALTABLETANDA202286a494c3a4-c42b-7aa3-5dde-12cb645b08b2
3669930090NDA AUTHORIZED GENERICPrasco Laboratories2010-05-17TRANEXAMIC ACIDORALTABLETNDA022430add851b1-0f2d-46e9-b122-f4f5ff216539
4669930121NDA AUTHORIZED GENERICPrasco Laboratories2010-05-17TRANEXAMIC ACIDORALTABLETNDA02243003003067-1bbc-4f5b-85ec-c21a955fbc06

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290084ANDAGolden State Medical Supply, Inc.2014-08-20TRANEXAMIC ACIDORALTABLET605053638ANDA2022860369e77d-94da-488f-bc9b-e9a68bc13da3
2680840929ANDAAmerican Health Packaging2015-03-31TRANEXAMIC ACIDORALTABLET, FILM COATED005913720ANDA2020933c47059e-50d9-4e40-910e-67d199458b5e

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA202093TRANEXAMIC ACIDACTAVIS LABORATORIES FL INC2012-12-27ANDA202093_001
2ANDA202286TRANEXAMIC ACIDAPOTEX INC2014-01-27ANDA202286_001
3ANDA205133TRANEXAMIC ACIDMYLAN PHARMACEUTICALS2015-09-21ANDA205133_001
4NDA019280CYKLOKAPRONTruePHARMACIA AND UPJOHN CO1986-12-30NDA019280_001
5NDA022430LYSTEDAFERRING PHARMACEUTICALS AS2009-11-13p8957113, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING, SUBSTANCE
p8487005, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING, SUBSTANCE
p8273795, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
p8791160, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING, SUBSTANCE
p8809394, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING, SUBSTANCE
p9060939, SUBSTANCE
p8022106, TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
p7947739, SUBSTANCE
NDA022430_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202093_001RXTRANEXAMIC ACID (650MG)ORALTABLETFalseAB2012-12-27TRANEXAMIC ACID
2ANDA202286_001RXTRANEXAMIC ACID (650MG)ORALTABLETFalseAB2014-01-27TRANEXAMIC ACID
3ANDA205133_001RXTRANEXAMIC ACID (650MG)ORALTABLETFalseAB2015-09-21TRANEXAMIC ACID
4NDA019280_001discontinuedTRANEXAMIC ACID (500MG)ORALTABLETFalse1986-12-30CYKLOKAPRON
5NDA022430_001RXTRANEXAMIC ACID (650MG)ORALTABLETTrueAB2009-11-13LYSTEDA

patent(s)

#idexpiration dateapplication(s)
1p7947739 (view patent)2025-03-04NDA022430
2p8022106 (view patent)2025-03-04NDA022430
3p8273795 (view patent)2025-03-04NDA022430
4p8487005 (view patent)2025-03-04NDA022430
5p8791160 (view patent)2025-03-04NDA022430
6p8809394 (view patent)2025-03-04NDA022430
7p8957113 (view patent)2025-03-04NDA022430
8p9060939 (view patent)2025-03-04NDA022430

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103003067-1bbc-4f5b-85ec-c21a955fbc06 (view SPL)These highlights do not include all the information needed to use Tranexamic Acid Tablets safely and effectively. See full prescribing information for Tranexamic Acid Tablets. Tranexamic Acid TabletsInitial U.S. Approval: 1986prescriptionHuman PrescriptionPrasco LaboratoriesMANUFACTURE, PACK2013-10-011669930121
20369e77d-94da-488f-bc9b-e9a68bc13da3 (view SPL)These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-311604290084
33c47059e-50d9-4e40-910e-67d199458b5e (view SPL)These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets.TRANEXAMIC ACID tablets, for oral useInitial U.S. Approval: 1986prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-301680840929
43f07e93b-3568-487e-894f-8f90e5a0960a (view SPL)These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-07-0110005913720
549317334-a833-4620-a3b5-f179f8a821e2 (view SPL)These highlights do not include all the information needed to use LYSTEDA safely and effectively. See full prescribing information for LYSTEDA. LYSTEDA (tranexamic acid) Tablets Initial U.S. Approval: 1986prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.MANUFACTURE, PACK2013-10-311555662110
684a65305-65d7-e7fd-66f3-dda8d8f920b1 (view SPL)These highlights do not include all the information needed to use LYSTEDA safely and effectively. See full prescribing information for LYSTEDA. LYSTEDA (tranexamic acid) Tablets Initial U.S. Approval: 1986prescriptionHuman PrescriptionFerring Pharmaceuticals Inc.MANUFACTURE, PACK2011-04-0110555662100
7a494c3a4-c42b-7aa3-5dde-12cb645b08b2 (view SPL)These highlights do not include all the information needed to use tranexamic acid tablets safely and effectively. See full prescribing information for tranexamic acid tablets. TRANEXAMIC ACID tablets, for oral use Initial U.S. Approval: 1986prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2013-10-152605053638
8add851b1-0f2d-46e9-b122-f4f5ff216539 (view SPL)These highlights do not include all the information needed to use Tranexamic Acid Tablets safely and effectively. See full prescribing information for Tranexamic Acid Tablets. Tranexamic Acid TabletsInitial U.S. Approval: 1986prescriptionHuman PrescriptionPrasco LaboratoriesMANUFACTURE, PACK2012-10-011669930090

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