FDA.reportPublic FDA data

Application 020209

Type
NDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXISTATOXICONAZOLE NITRATELOTION;TOPICALEQ 1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10337-359Oxistatoxiconazole nitratePharmaDerm a division of Fougera Pharmaceuticals Inc.NDACurrent
10337-359Oxistatoxiconazole nitratePharmaDerm a division of Fougera Pharmaceuticals Inc.NDACurrent
21695-459Oxistatoxiconazole nitrateRebel Distributors Corp.NDACurrent
62559-285Oxistatoxiconazole nitrateANI Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71629SUPPL2022-07-25
71146SUPPL2022-05-25
34369SUPPL2004-02-02
24577SUPPL2004-01-29