APPLICATION
ANDA203413
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-16
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLAFEM 0.5/35Discontinued
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.5MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 2 · standardAP
2022-02-08Labeling · Supplement 1 · standardAP
2015-12-16UNKNOWN · OriginalAP
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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