FDA.report

Application 075581

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001KETOCONAZOLEKETOCONAZOLECREAM;TOPICAL2%NoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3219KetoconazoleKetoconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3219KetoconazoleKetoconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3219KetoconazoleKetoconazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0713-0671KetoconazoleKetoconazoleG&W Laboratories, Inc.ANDACurrent
50090-3207KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
50090-3299KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
50090-5265KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
50090-5265KetoconazoleKetoconazoleA-S Medication SolutionsANDACurrent
63629-8819KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
63629-8819KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
63629-8820KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
63629-8820KetoconazoleKetoconazoleBryant Ranch PrepackANDACurrent
68071-2309KetoconazoleKetoconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2309KetoconazoleKetoconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7755KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7755KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7755KetoconazoleKetoconazolePreferred Pharmaceuticals, Inc.ANDACurrent
70518-3367KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent
70518-3367KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent
70518-3367KetoconazoleKetoconazoleREMEDYREPACK INC.ANDACurrent

Documents

DocumentSubmission typeDate
43005ORIG2000-04-25
30945ORIG2000-04-25
18414ORIG2000-04-25