FDA.reportPublic FDA data

Application 204654

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LO MINASTRIN FEETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLET, CHEWABLE, TABLET;ORAL0.01MG,0.01MG,N/A;1MG,N/A,N/AYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0430-0537Lo Minastrin Fenorethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarateAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49381SUPPL2017-08-15
49302SUPPL2017-08-09
48869SUPPL2017-06-29
48865SUPPL2017-06-29
43472ORIG2014-03-06
24476ORIG2014-03-06
40406ORIG2013-07-30
32577ORIG2013-07-26