APPLICATION
ANDA202016
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-26
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MELAMISAPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL
Approval history
2025-03-21Labeling · Supplement 7 · standardAP
2025-03-21Labeling · Supplement 1 · standardAP
2025-03-21Labeling · Supplement 8 · standardAP
2016-01-26OriginalAP
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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