APPLICATION
ANDA078935
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-26
LATEST ACTION
2015-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2015-06-30Labeling · Supplement 6 · standardAP
2015-06-30Labeling · Supplement 9 · standardAP
2015-06-30Labeling · Supplement 5 · standardAP
2011-01-25Labeling · Supplement 2AP
2010-05-26OriginalAP
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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