FDA.reportPublic FDA data

Application 204426

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAYTULLAETHINYL ESTRADIOL; NORETHINDRONE ACETATECAPSULE;ORAL0.02MG;1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5862Taytullanorethindrone acetate and ethinyl estradiol, and ferrous fumarateAllergan, Inc.NDACurrent
0023-5862Taytullanorethindrone acetate and ethinyl estradiol, and ferrous fumarateAllergan, Inc.NDACurrent
0023-5862Taytullanorethindrone acetate and ethinyl estradiol, and ferrous fumarateAllergan, Inc.NDACurrent
0023-5862Taytullanorethindrone acetate and ethinyl estradiol, and ferrous fumarateAllergan, Inc.NDACurrent
0430-0539norethindrone acetate and ethinyl estradiol and ferrous fumaratenorethindrone acetate and ethinyl estradiol, and ferrous fumarateWarner Chilcott (US), LLCNDACurrent
59762-1599norethindrone acetate and ethinyl estradiol and ferrous fumaratenorethindrone acetate and ethinyl estradiol, and ferrous fumarateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1599norethindrone acetate and ethinyl estradiol and ferrous fumaratenorethindrone acetate and ethinyl estradiol, and ferrous fumarateGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74638SUPPL 2023-06-27
74634SUPPL 2023-06-27
70951SUPPL2022-05-03
70893SUPPL2022-05-02
49474SUPPL2017-08-21
49364SUPPL2017-08-15
45107SUPPL2016-08-23
45153SUPPL2016-08-19
40390SUPPL2015-07-24
24470ORIG2013-09-26
22957ORIG2013-09-26
32558ORIG2013-04-24
19559ORIG2013-04-23
51412ORIG1900-01-01
51411ORIG1900-01-01
51410ORIG1900-01-01