FDA.reportPublic FDA data

Application 076005

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ECONAZOLE NITRATEECONAZOLE NITRATECREAM;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-956Econazole NitrateEconazole NitrateAidarex Pharmaceuticals LLCANDACurrent
51672-1303Econazole NitrateEconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1303Econazole NitrateEconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1303Econazole NitrateEconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
68788-8174Econazole NitrateEconazole NitratePreferred Pharmaceuticals Inc.ANDACurrent
68788-9848Econazole NitrateEconazole NitratePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43045ORIG2003-12-24
31059ORIG2003-12-24
18438ORIG2003-12-24