APPLICATION
ANDA072694
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-28
LATEST ACTION
2022-04-29
ROUTE
ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GENCEPT 10/11-21Discontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG, NORETHINDRONE 0.5MG,1MG · TABLET · ORAL-21
Approval history
2022-04-29Labeling · Supplement 2 · standardAP
2017-08-09Labeling · Supplement 1 · standardAP
1992-02-28OriginalAP
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.
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