APPLICATION
ANDA077075
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-28
LATEST ACTION
2014-11-28
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GILDESS 1.5/30Discontinued
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21
GILDESS FE 1.5/30Discontinued
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28
Approval history
2014-11-28Labeling · Supplement 7 · standardAP
2014-04-30Manufacturing (CMC) · Supplement 11 · unknownAP
2009-03-27Labeling · Supplement 2AP
2005-04-28OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.