APPLICATION
ANDA075960
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-19
LATEST ACTION
2008-02-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2008-02-06Manufacturing (CMC) · Supplement 9AP
2005-08-22Labeling · Supplement 5AP
2002-10-17Labeling · 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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