APPLICATION
ANDA090114
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-28
LATEST ACTION
2023-09-22
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SYEDAPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2023-09-22Labeling · Supplement 18 · standardAP
2023-04-20Labeling · Supplement 16 · standardAP
2023-04-20Labeling · Supplement 14 · standardAP
2023-04-20Labeling · Supplement 11 · standardAP
2015-06-13Labeling · Supplement 5 · standardAP
2011-08-02Labeling · Supplement 1AP
2011-03-28OriginalAP
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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