APPLICATION
ANDA075962
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-24
LATEST ACTION
2024-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2024-10-31REMS · Supplement 12AP
2023-12-18Labeling · Supplement 10 · standardAP
2018-09-18REMS · Supplement 9AP
2005-01-03Labeling · Supplement 5AP
2004-11-18Labeling · Supplement 6AP
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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