APPLICATION
ANDA078515
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-30
LATEST ACTION
2015-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DROSPIRENONE AND ETHINYL ESTRADIOLDiscontinued
DROSPIRENONE 3MG, ETHINYL ESTRADIOL 0.02MG · TABLET · ORAL
Approval history
2015-10-06Labeling · Supplement 10 · standardAP
2015-10-06Labeling · Supplement 11 · standardAP
2010-07-02Labeling · Supplement 7AP
2010-07-02Labeling · Supplement 5AP
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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