APPLICATION
ANDA077182
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-24
LATEST ACTION
2019-10-25
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
DESOGESTREL; ETHINYL ESTRADIOLPrescription
DESOGESTREL 0.125MG/0.025MG, ETHINYL ESTRADIOL · TABLET · ORAL-28
DESOGESTREL; ETHINYL ESTRADIOLPrescription
DESOGESTREL 0.15MG/0.025MG, ETHINYL ESTRADIOL · TABLET · ORAL-28
DESOGESTREL AND ETHINYL ESTRADIOLDiscontinued
DESOGESTREL 0.1MG,0.125MG,0.15MG, ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG · TABLET · ORAL-28
Approval history
2019-10-25Labeling · Supplement 14 · standardAP
2010-08-02Labeling · Supplement 8AP
2009-03-19Labeling · Supplement 4AP
2006-01-24OriginalAP
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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