APPLICATION
ANDA090293
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-01
LATEST ACTION
2025-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GILDESS 24 FEDiscontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL
Approval history
2025-07-08Labeling · Supplement 6 · standardAP
2025-07-08Labeling · Supplement 4 · standardAP
2025-07-08Labeling · Supplement 2 · standardAP
2025-07-08Labeling · Supplement 5 · standardAP
2025-07-08Labeling · Supplement 3 · standardAP
2014-12-01OriginalAP
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.
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