FDA.reportPublic FDA data

Application 200245

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.02MG;0.1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-7287LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
50090-2534LEVONORGESTREL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50102-120AUBRALevonorgestrel and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-120AUBRALevonorgestrel and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-120AUBRALevonorgestrel and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
53002-1692AUBRALevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1692AUBRALevonorgestrel and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent