FDA.reportPublic FDA data

Application 022573

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONETABLET, CHEWABLE;ORAL0.025MG;0.8MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6030GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
0023-6030GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
0023-6030GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
0023-6030GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent
52544-064Layolis Fenorethindrone, ethinyl estradiol, and ferrous fumarateActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
52544-064Layolis Fenorethindrone, ethinyl estradiol, and ferrous fumarateActavis Pharma, Inc.NDACurrent
52544-064Layolis Fenorethindrone, ethinyl estradiol, and ferrous fumarateActavis Pharma, Inc.NDACurrent
52544-064Layolis Fenorethindrone, ethinyl estradiol, and ferrous fumarateActavis Pharma, Inc.NDACurrent
52544-204GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateActavis Pharma, Inc.NDACurrent
52544-204GENERESS Fenorethindrone and ethinyl estradiol and ferrous fumarateActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74636SUPPL 2023-06-27
74632SUPPL 2023-06-27
70969SUPPL2022-05-04
70944SUPPL2022-05-03
49385SUPPL2017-08-15
49304SUPPL2017-08-09
44781ORIG2011-07-26
42561ORIG2011-07-26
29874ORIG2010-12-28
17727ORIG2010-12-26
63531ORIG1900-01-01
63530ORIG1900-01-01
63529ORIG1900-01-01