FDA.reportPublic FDA data

Application 205441

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-MILIETHINYL 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
50090-3793Tri-MiliNorgestimate and Ethinyl EstradiolA-S Medication SolutionsANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
50102-233Tri-VyLibraNorgestimate and Ethinyl EstradiolAfaxys Pharma, LLCANDACurrent
53002-1776Tri-VyLibraNorgestimate and Ethinyl EstradiolRPK Pharmaceuticals, Inc.ANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-777Tri-MiliNorgestimate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent