FDA.reportPublic FDA data

Application 075597

Type
ANDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0261KetoconazoleketoconazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-0261KetoconazoleketoconazoleMylan Pharmaceuticals Inc.ANDACurrent
43063-036KetoconazoleketoconazolePD-Rx Pharmaceuticals, InANDACurrent
43063-036KetoconazoleketoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-036KetoconazoleketoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1992KetoconazoleketoconazoleA-S Medication SolutionsANDACurrent
53808-0842KetoconazoleketoconazoleState of Florida DOH Central PharmacyANDACurrent
68084-552KetoconazoleketoconazoleAmerican Health PackagingANDACurrent
70518-2027KetoconazoleketoconazoleREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8732ORIG1999-12-23