FDA.reportPublic FDA data

Application 091663

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG;0.15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLethinyl estradiol and levonorgestrelMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOLlevonorgestrel and ethinyl estradiolMylan Pharmaceuticals Inc.ANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
50102-130CHATEALlevonorgestrel and ethinyl estradiolAfaxys Pharma, LLCANDACurrent
53002-1683CHATEALlevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent
53002-1683CHATEALlevonorgestrel and ethinyl estradiolRPK Pharmaceuticals, Inc.ANDACurrent