APPLICATION
ANDA078665
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-28
LATEST ACTION
2012-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEVONORGESTRELDiscontinued
LEVONORGESTREL 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2012-09-26Labeling · Supplement 5AP
2010-09-01Labeling · Supplement 1AP
2009-08-28OriginalAP
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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