FDA.reportPublic FDA data

Application 207581

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AUROVELA 1.5/30ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-210.03MG;1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent
65862-935Aurovela 1.5/30Norethindrone Acetate and Ethinyl EstradiolAurobindo Pharma LimitedANDACurrent