APPLICATION
ANDA202226
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-12
LATEST ACTION
2025-03-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BEKYREEPrescription
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28
Approval history
2025-03-03Labeling · Supplement 14 · standardAP
2025-03-03Labeling · Supplement 15 · standardAP
2022-04-29Labeling · Supplement 12 · standardAP
2020-03-30Labeling · Supplement 7 · standardAP
2020-03-30Labeling · Supplement 4 · standardAP
2017-08-09Labeling · Supplement 3 · standardAP
2015-08-12OriginalAP
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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