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FDA ANDA · ANDA202246

LEVONORGESTREL

Sponsor: ALVOGEN

APPLICATION
ANDA202246
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-05
LATEST ACTION
2018-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVONORGESTRELDiscontinued
LEVONORGESTREL 1.5MG · TABLET · ORAL

Approval history

2018-02-20Labeling · Supplement 4 · standardAP
2016-07-06Labeling · Supplement 3 · standardAP
2016-07-06Labeling · Supplement 1 · standardAP
2015-06-05OriginalAP
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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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