APPLICATION
ANDA211944
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-22
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DROSPIRENONE AND ETHINYL ESTRADIOLPrescription
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL
Approval history
2023-08-16Labeling · Supplement 5 · standardAP
2023-08-16Labeling · Supplement 2 · standardAP
2019-03-22UNKNOWN · 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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