FDA.reportPublic FDA data

Application 090523

Type
ANDA
Sponsor
NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONO-LINYAHETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG;0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-360Mono-Linyahnorgestimate and ethinyl estradiolNorthstar Rx LLCANDACurrent
50090-3426Mono-Linyahnorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
50090-4881Mono-Linyahnorgestimate and ethinyl estradiolA-S Medication SolutionsANDACurrent
51862-645Nymyonorgestimate and ethinyl estradiolMayne Pharma Inc.ANDACurrent
51862-645Nymyonorgestimate and ethinyl estradiolMayne Pharma Inc.ANDACurrent