FDA.reportPublic FDA data

Application 090719

Type
ANDA
Sponsor
NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVONESTETHINYL ESTRADIOL; LEVONORGESTRELTABLET;ORAL-280.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-340Levonestlevonorgestrel and ethinyl estradiolNorthstar Rx LLCANDACurrent
16714-340Levonestlevonorgestrel and ethinyl estradiolNorthstar Rx LLCANDACurrent
50090-2505Levonestlevonorgestrel and ethinyl estradiolA-S Medication SolutionsANDACurrent