FDA.reportPublic FDA data

Application 214292

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATENORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATECAPSULE;ORAL0.02MG;1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-558TAYSOFYNorethindrone Acetate and Ethinyl Estradiol, and Ferrous FumarateAmneal Pharmaceuticals LLCANDACurrent
65162-558TAYSOFYNorethindrone Acetate and Ethinyl Estradiol, and Ferrous FumarateAmneal Pharmaceuticals LLCANDACurrent
69238-1686Norethindrone Acetate and Ethinyl Estradiol, and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol, and Ferrous FumarateAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67814ORIG2021-06-15