FDA.reportPublic FDA data

Application 021490

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEMCON FEETHINYL ESTRADIOL; NORETHINDRONETABLET, CHEWABLE;ORAL0.035MG;0.4MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5970FEMCON Fenorethindrone and ethinyl estradiol, and ferrous fumarateAllergan, Inc.NDACurrent
68180-897Norethindrone and Ethinyl Estradiol and Ferrous FumarateNorethindrone and Ethinyl EstradiolLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-898WYMZYA FEnorethindrone and ethinyl estradiol, and ferrous fumarateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68180-899WYMZYA FEnorethindrone and ethinyl estradiol, and ferrous fumarateLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49377SUPPL2017-08-15
49300SUPPL2017-08-09
45528SUPPL2016-10-12
45416SUPPL2016-09-29
15593SUPPL2008-01-18
5533SUPPL2008-01-15
5532SUPPL2007-02-12
15592SUPPL2007-02-02
21690ORIG2005-02-02
5531ORIG2003-11-28
37062ORIG2003-11-14