FDA.reportPublic FDA data

Application 086069

Type
ANDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRACEESTRADIOLCREAM;VAGINAL0.01%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3541EstradiolEstradiolTeva Pharmaceuticals USA, Inc.ANDACurrent
0430-3754ESTRACEestradiolAllergan, Inc.ANDACurrent
0430-3754ESTRACEestradiolAllergan, Inc.ANDACurrent
0430-3754ESTRACEestradiolAllergan, Inc.ANDACurrent
0430-3754ESTRACEestradiolAllergan, Inc.ANDACurrent
0430-3754ESTRACEestradiolAllergan, Inc.ANDACurrent
50090-2321ESTRACEestradiolA-S Medication SolutionsANDACurrent
50090-2321ESTRACEestradiolA-S Medication SolutionsANDACurrent
50090-2321ESTRACEestradiolA-S Medication SolutionsANDACurrent
50090-3327EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-3327EstradiolEstradiolA-S Medication SolutionsANDACurrent
50090-3327EstradiolEstradiolA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78033SUPPL 2024-04-02
78032SUPPL 2024-04-02
39592SUPPL2015-05-27
22672SUPPL2015-05-27