FDA.reportPublic FDA data

Application 017765

Type
NDA
Sponsor
EPI HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLODERMCLOCORTOLONE PIVALATECREAM;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-341clocortolone pivalateclocortolone pivalateDr. Reddy's Laboratories IncNDA AUTHORIZED GENERICCurrent
43598-341clocortolone pivalateclocortolone pivalateDr. Reddy's Laboratories IncNDA AUTHORIZED GENERICCurrent
66993-947Clocortolone Pivalate CreamClocortolone PivalatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-947Clocortolone Pivalate CreamClocortolone PivalatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
67857-804Clodermclocortolone pivalatePromius Pharma, LLCNDACurrent
67857-804Clodermclocortolone pivalatePromius Pharma, LLCNDACurrent
71403-804Clodermclocortolone pivalateEPI Health, IncNDACurrent
71403-804Clodermclocortolone pivalateEPI Health, IncNDACurrent
71403-804Clodermclocortolone pivalateEPI Health, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13894SUPPL2003-12-16
11058SUPPL2003-12-16