FDA ANDA · ANDA205049
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Sponsor: XIROMED
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APPLICATION
ANDA205049
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-31
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEDiscontinued
ETHINYL ESTRADIOL 0.01MG,0.01MG, NORETHINDRONE ACETATE 1MG,N/A · TABLET · ORAL
Approval history
2026-10-14Labeling · Supplement 10 · standardAP
2026-07-13Labeling · Supplement 6 · standardAP
2026-07-13Labeling · Supplement 5 · standardAP
2018-11-20Labeling · Supplement 2 · standardAP
2018-11-20Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →