APPLICATION
ANDA202015
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-19
LATEST ACTION
2023-10-24
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
YAELAPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2023-10-24Labeling · Supplement 7 · standardAP
2023-10-24Labeling · Supplement 1 · standardAP
2023-10-24Labeling · Supplement 8 · standardAP
2014-11-19OriginalAP
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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