FDA.reportPublic FDA data

Application 209483

Type
NDA
Sponsor
ENCORE DERMAT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMPOYZCLOBETASOL PROPIONATECREAM;TOPICAL0.025%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67857-811IMPOYZClobetasol PropionatePromius Pharma, LLC.NDACurrent
68040-713Impoyzclobetasol propionatePrimus Pharmaceuticals, Inc.NDACurrent
69482-700Impoyzclobetasol propionateEncore Dermatology, IncNDACurrent
69482-700Impoyzclobetasol propionateEncore Dermatology, IncNDACurrent
69482-700Impoyzclobetasol propionateEncore Dermatology, IncNDACurrent
69482-700Impoyzclobetasol propionateEncore Dermatology, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52959ORIG2018-03-14
50561ORIG2017-12-01
50524ORIG2017-11-29