FDA.reportPublic FDA data

Application 019257

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARNITORLEVOCARNITINESOLUTION;ORAL1GM/10MLYesYes
002CARNITOR SFLEVOCARNITINESOLUTION;ORAL1GM/10MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-171LevocarnitineLevocarnitineAkornNDACurrent
50383-171LevocarnitineLevocarnitineAkornNDACurrent
50383-171LevocarnitineLevocarnitineHi-Tech Pharmacal Co., Inc.NDACurrent
50383-171LevocarnitineLevocarnitineHi-Tech Pharmacal Co., Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-145CarnitorlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent
54482-148Carnitor SFlevocarnitineLeadiant Biosciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53760SUPPL2018-04-20
53735SUPPL2018-04-19
11460SUPPL2015-06-04
17336SUPPL2015-06-02
1262SUPPL2007-04-09
11459SUPPL2007-03-31
33711SUPPL2002-04-15
1261SUPPL2002-04-15