FDA.reportPublic FDA data

Application 213138

Type
NDA
Sponsor
CUBIST PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFICIDFIDAXOMICINFOR SUSPENSION;ORAL40MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme Corp.NDACurrent
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme Corp.NDACurrent
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme LLCNDACurrent
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme LLCNDACurrent
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme Corp.NDACurrent
52015-700DIFICIDFIDAXOMICINMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63569ORIG2020-06-15
63361SUPPL2020-06-01
63348SUPPL2020-05-29
61697ORIG2020-01-27
61695ORIG2020-01-27
62998ORIG1900-01-01