APPLICATION
ANDA203291
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-18
LATEST ACTION
2020-06-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DROSPIRENONE AND ETHINYL ESTRADIOLPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL
Approval history
2020-06-04Labeling · Supplement 1 · standardAP
2017-07-18UNKNOWN · 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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