FDA.reportPublic FDA data

Application 203667

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINASTRIN 24 FEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET, CHEWABLE;ORAL0.02MG;1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0430-0540Minastrin 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
0430-0540Minastrin 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
0430-0540Minastrin 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
52544-058Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-058Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-058Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-058Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-058Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNorethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74637SUPPL 2023-06-27
74633SUPPL 2023-06-27
70946SUPPL2022-05-03
70910SUPPL2022-05-03
49383SUPPL2017-08-15
49301SUPPL2017-08-09
46483SUPPL2016-12-22
46495SUPPL2016-12-21
40319SUPPL2014-12-16
32457SUPPL2014-12-09
24444ORIG2013-09-20
22931ORIG2013-09-20
19489SUPPL2013-07-12
10243SUPPL2013-07-12
40318ORIG2013-05-14
32456ORIG2013-05-10