FDA.reportPublic FDA data

Application 022430

Type
NDA
Sponsor
FERRING PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LYSTEDATRANEXAMIC ACIDTABLET;ORAL650MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-772Tranexamic AcidTranexamic AcidAvPAKNDA AUTHORIZED GENERICCurrent
55566-2110LystedaTranexamic AcidFerring Pharmaceuticals Inc.NDACurrent
55566-2110LystedaTranexamic AcidFerring Pharmaceuticals Inc.NDACurrent
55566-2110LystedaTranexamic AcidFerring Pharmaceuticals Inc.NDACurrent
55566-2110LystedaTranexamic AcidFerring Pharmaceuticals Inc.NDACurrent
66993-090Tranexamic AcidTranexamic AcidPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-121Tranexamic AcidTranexamic AcidPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
69918-300LystedaTranexamic AcidAmring Pharmaceuticals Inc.NDACurrent
69918-300LystedaTranexamic AcidAmring Pharmaceuticals Inc.NDACurrent
69918-301Tranexamic AcidTranexamic AcidAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-301Tranexamic AcidTranexamic AcidAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-301Tranexamic AcidTranexamic AcidAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-301Tranexamic AcidTranexamic AcidAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
69918-301Tranexamic AcidTranexamic AcidAmring Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
71335-1957Tranexamic AcidTranexamic AcidBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-1957Tranexamic AcidTranexamic AcidBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65569SUPPL2020-12-10
65537SUPPL2020-12-09
38705SUPPL2013-10-08
29726SUPPL2013-10-04
17584SUPPL2013-08-22
7388SUPPL2013-08-22
42523SUPPL2011-10-10
7387SUPPL2011-04-11
17583SUPPL2011-04-07
42522ORIG2010-05-06
24306ORIG2010-05-06
7386ORIG2009-11-19
38704ORIG2009-11-17
51496ORIG1900-01-01