FDA.reportPublic FDA data

Application 021946

Type
NDA
Sponsor
ALMIRALL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XOLEGELKETOCONAZOLEGEL;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16110-080XolegelketoconazoleAlmirall, LLCNDACurrent
16110-080XolegelketoconazoleAlmirall, LLCNDACurrent
16110-080XolegelketoconazoleAqua PharmaceuticalsNDACurrent
16110-080XolegelketoconazoleAqua PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61497SUPPL2020-01-02
61460SUPPL2019-12-27
37934SUPPL2012-05-16
6516SUPPL2012-05-14
28903SUPPL2010-12-10
16622SUPPL2010-12-06
6515SUPPL2010-01-05
16621SUPPL2010-01-04
16620SUPPL2009-01-06
21882ORIG2008-09-04
28902ORIG2006-08-04
16619ORIG2006-08-04