FDA.reportPublic FDA data

Application 205175

Type
NDA
Sponsor
GLENMARK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ECOZAECONAZOLE NITRATEAEROSOL, FOAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23710-100ECOZAeconazole nitrateExeltis USA Dermatology, LLCNDACurrent
23710-100ECOZAeconazole nitrateQuinnova Pharmaceuticals, LLCNDACurrent
23710-100ECOZAeconazole nitrateExeltis USA Dermatology, LLCNDACurrent
23710-100ECOZAeconazole nitrateExeltis USA Dermatology, LLCNDACurrent
72657-200ECOZAeconazole nitrateGlenmark Therapeutics Inc.,USANDACurrent
72657-200ECOZAeconazole nitrateGlenmark Therapeutics Inc.,USANDACurrent
72657-200ECOZAeconazole nitrateGlenmark Therapeutics Inc.,USANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60975SUPPL2019-11-20
60971SUPPL2019-11-19
24488ORIG2014-06-27
22979ORIG2014-06-27
40455ORIG2013-10-25
10430ORIG2013-10-25
52445ORIG1900-01-01
52444ORIG1900-01-01
52440ORIG1900-01-01