FDA.reportPublic FDA data

Application 075953

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERCONAZOLETERCONAZOLECREAM;VAGINAL0.8%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1196TerconazoleTerconazoleA-S Medication SolutionsANDACurrent
50090-1196TerconazoleTerconazoleA-S Medication SolutionsANDACurrent
50090-1196TerconazoleTerconazoleA-S Medication SolutionsANDACurrent
51672-1302TerconazoleTerconazoleTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1302TerconazoleTerconazoleTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1302TerconazoleTerconazoleTaro Pharmaceuticals U.S.ANDACurrent
53002-7240TerconazoleTerconazoleRPK Pharmaceuticals, Inc.ANDACurrent
53002-7240TerconazoleTerconazoleRPK Pharmaceuticals, Inc.ANDACurrent
68071-1626TerconazoleTerconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1626TerconazoleTerconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1626TerconazoleTerconazoleNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1185TerconazoleTerconazoleREMEDYREPACK INC.ANDACurrent
70518-1185TerconazoleTerconazoleREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43040ORIG2007-07-06