FDA.reportPublic FDA data

Application 021758

Type
NDA
Sponsor
MEDICIS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68682-992FluocinonidefluocinonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-992FluocinonidefluocinonideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
99207-525VanosfluocinonideBausch Health US, LLCNDACurrent
99207-525VanosfluocinonideBausch Health US LLCNDACurrent
99207-525VanosfluocinonideValeant Pharmaceuticals North America LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
37593SUPPL2012-03-20
28535SUPPL2012-03-19
16320SUPPL2011-11-16
6131SUPPL2011-11-16
28534SUPPL2011-01-05
16319SUPPL2010-12-30
28533SUPPL2010-03-10
37592SUPPL2010-03-09
42301ORIG2007-07-18
28532SUPPL2006-12-28
37591SUPPL2006-12-26
37590SUPPL2006-03-03
6130SUPPL2006-03-03
28531SUPPL2005-11-30
16318ORIG2005-02-17
6129ORIG2005-02-17