APPLICATION
ANDA078569
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-14
LATEST ACTION
2015-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ACETAMINOPHENDiscontinued
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2015-08-10Labeling · Supplement 1AP
2015-08-10Labeling · Supplement 4 · standardAP
2011-12-14OriginalAP
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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