APPLICATION
ANDA205876
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-21
LATEST ACTION
2023-09-12
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DROSPIRENONE AND ETHINYL ESTRADIOLDiscontinued
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.03MG · TABLET · ORAL-28
Approval history
2023-09-12Labeling · Supplement 7 · standardAP
2023-05-19Labeling · Supplement 3 · standardAP
2023-05-19Labeling · Supplement 6 · standardAP
2016-09-21UNKNOWN · Original · standardAP
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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