FDA.reportPublic FDA data

Application 200493

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL0.02MG,0.1MG;0.01MG,N/ANoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7284LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-7284LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLLevonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolMylan Pharmaceuticals Inc.ANDACurrent
57994-008LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolJai Pharma LimitedANDACurrent