APPLICATION
ANDA091663
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-21
LATEST ACTION
2023-02-06
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2023-02-06Labeling · Supplement 13 · standardAP
2022-04-29Labeling · Supplement 12 · standardAP
2022-03-04Labeling · Supplement 11 · standardAP
2022-03-04Labeling · Supplement 8 · standardAP
2017-08-09Labeling · Supplement 7 · standardAP
2014-01-29Labeling · Supplement 1 · standardAP
2012-12-21Not Applicable · 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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