FDA.reportPublic FDA data

Application 079218

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG;0.09MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0480-3472AmethystLevonorgestrel and Ethinyl EstradiolTeva Pharmaceuticals, Inc.ANDACurrent
0591-0295Levonorgestrel and Ethinyl EstradiolLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-295AmethystLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-295AmethystLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-295AmethystLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-295AmethystLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent
52544-295AmethystLevonorgestrel and Ethinyl EstradiolActavis Pharma, Inc.ANDACurrent