APPLICATION
ANDA202689
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-09
LATEST ACTION
2024-05-15
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VOLNEAPrescription
DESOGESTREL 0.15MG,N/A, ETHINYL ESTRADIOL 0.02MG,0.01MG · TABLET · ORAL-28
Approval history
2024-05-15Labeling · Supplement 6 · standardAP
2022-04-29Labeling · Supplement 5 · standardAP
2017-08-09Labeling · Supplement 1 · standardAP
2016-09-09UNKNOWN · 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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