FDA.reportPublic FDA data

Application 076419

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLESHAMPOO;TOPICAL2%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-465KetoconazoleKetoconazolePerrigo New York IncANDACurrent
45802-465KetoconazoleKetoconazolePadagis Israel Pharmaceuticals LtdANDACurrent
50090-1220KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
50090-1220KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
50090-1220KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
53217-015KetoconazoleKetoconazoleAidarex Pharmaceuticals LLCANDACurrent
63629-8675KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
63629-8675KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
63629-8675KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
68788-9903KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9903KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9903KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9903KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9903KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43075ORIG2007-04-02