APPLICATION
ANDA078376
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-06
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GILDAGIADiscontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 5 · standardAP
2017-08-09Labeling · Supplement 4 · standardAP
2012-11-06OriginalAP
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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