FDA.reportPublic FDA data

Application 090524

Type
ANDA
Sponsor
NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-LINYAHETHINYL ESTRADIOL; NORGESTIMATETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-363Tri-LinyahNorgestimate and Ethinyl EstradiolNorthstar Rx LLCANDACurrent
51862-646Tri-NymyoNorgestimate and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent
51862-646Tri-NymyoNorgestimate and Ethinyl EstradiolMayne Pharma Inc.ANDACurrent