APPLICATION
ANDA202508
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-22
LATEST ACTION
2016-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LEVONORGESTRELOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL
Approval history
2016-06-03Labeling · Supplement 4 · standardAP
2014-03-19Labeling · Supplement 3 · standardAP
2014-03-19Labeling · Supplement 1AP
2013-02-22UNKNOWN · 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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