FDA.reportPublic FDA data

Application 020130

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTROSTEP 21ETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-210.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ESTROSTEP FEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET;ORAL-280.02MG,0.03MG,0.035MG;1MG,1MG,1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0430-0005ESTROSTEP FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAllergan, Inc.NDACurrent
0430-0005ESTROSTEP FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAllergan, Inc.NDACurrent
0430-0005ESTROSTEP FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAllergan, Inc.NDACurrent
0430-0005ESTROSTEP FeNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateAllergan, Inc.NDACurrent
51862-284Tilia FeNorethindrone Acetate and Ethinyl EstradiolMayne Pharma Inc.NDACurrent
51862-284Tilia FeNorethindrone Acetate and Ethinyl EstradiolMayne Pharma Inc.NDACurrent
51862-284Tilia FeNorethindrone Acetate and Ethinyl EstradiolMayne Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70970SUPPL2022-05-04
70927SUPPL2022-05-03
68107SUPPL2021-07-16
68091SUPPL2021-07-15
50031SUPPL2017-10-12
50012SUPPL2017-10-11
49420SUPPL2017-08-15
49305SUPPL2017-08-09
12239SUPPL2003-04-25
2050SUPPL2002-06-14
41149SUPPL1999-05-07