FDA.reportPublic FDA data

Application 211379

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEMADYDEXAMETHASONETABLET;ORAL20MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64239-300HEMADYDexamethasoneDexcel Pharma Technologies Ltd.NDACurrent
72893-015HemadyDexamethasoneAcrotech Biopharma LLCNDACurrent
72893-015HemadyDexamethasoneAcrotech Biopharma LLCNDACurrent
72893-015HemadyDexamethasoneAcrotech Biopharma LLCNDACurrent
72893-015HemadyDexamethasoneAcrotech Biopharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78727SUPPL 2024-07-02
78669SUPPL 2024-06-06
67924SUPPL2021-06-28
67917SUPPL2021-06-28
61458ORIG2019-12-27
60238ORIG2019-10-04
60220ORIG2019-10-03