FDA.reportPublic FDA data

Application 075273

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0900KetoconazoleKetoconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
68151-2713KetoconazoleKetoconazoleCarilion Materials ManagementANDACurrent
68788-9117KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42970ORIG1999-06-15
18402ORIG1999-06-15
8592ORIG1999-06-15