APPLICATION
ANDA076338
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-16
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLAFEM 7/7/7Discontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORETHINDRONE 0.5MG,0.75MG,1MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 12 · standardAP
2020-07-06Labeling · Supplement 10 · standardAP
2016-08-26Labeling · Supplement 9 · standardAP
2015-03-20Labeling · Supplement 6 · standardAP
2014-01-30Manufacturing (CMC) · Supplement 1AP
2010-11-16OriginalAP
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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