APPLICATION
ANDA075986
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-21
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2018-09-18REMS · Supplement 18AP
2015-11-09Labeling · Supplement 13 · standardAP
2014-10-28Manufacturing (CMC) · Supplement 12AP
2011-03-14Labeling · Supplement 11AP
2004-07-28Labeling · Supplement 3AP
2003-06-03Labeling · Supplement 1AP
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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