APPLICATION
ANDA202970
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-23
LATEST ACTION
2026-06-25
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.03MG,0.04MG,0.03MG, LEVONORGESTREL 0.05MG,0.075MG,0.125MG · TABLET · ORAL-28
Approval history
2026-06-25Labeling · Supplement 5 · standardAP
2022-04-29Labeling · Supplement 3 · standardAP
2021-02-17Labeling · Supplement 1 · standardAP
2018-03-23UNKNOWN · 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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