APPLICATION
ANDA207044
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-25
LATEST ACTION
2023-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LEVONORGESTRELOver-the-counter
LEVONORGESTREL 1.5MG · TABLET · ORAL
Approval history
2023-10-31Labeling · Supplement 3 · standardAP
2023-10-31Labeling · Supplement 1 · standardAP
2023-10-31Labeling · Supplement 4 · standardAP
2016-03-25UNKNOWN · 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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