FDA.reportPublic FDA data

Application 075319

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLETABLET;ORAL200MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-562KetoconazoleKetoconazoleRebel Distributors CorpANDACurrent
33261-739KetoconazoleKetoconazoleAidarex Pharmaceuticals LLCANDACurrent
43063-882KetoconazoleKetoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-882KetoconazoleKetoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-882KetoconazoleKetoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-882KetoconazoleKetoconazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
51672-4026KetoconazoleKetoconazoleTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
60429-020KetoconazoleKetoconazoleGolden State Medical Supply, Inc.ANDACurrent
60429-020KetoconazoleKetoconazoleGolden State Medical Supply Inc.ANDACurrent
68071-2902KetoconazoleKetoconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4012KetoconazoleKetoconazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9708KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9708KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9708KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0915KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent
70518-0915KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent
70518-0915KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent
71335-0439KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
71335-0439KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
71335-0439KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8617ORIG1999-06-15