APPLICATION
ANDA075983
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-25
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 17AP
2025-12-31Labeling · Supplement 16 · standardAP
2025-12-22Labeling · Supplement 14 · standardAP
2024-10-31REMS · Supplement 15AP
2023-12-15Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 12AP
2005-11-17Labeling · Supplement 11AP
2004-08-11Labeling · Supplement 8AP
2002-11-22Labeling · Supplement 4AP
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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