APPLICATION
ANDA075977
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-19
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 38AP
2025-12-22Labeling · Supplement 36 · standardAP
2025-12-11Labeling · Supplement 33 · standardAP
2024-10-31REMS · Supplement 34AP
2024-03-22Manufacturing (CMC) · Supplement 29 · unknownAP
2023-12-18Labeling · Supplement 32 · standardAP
2023-12-18Labeling · Supplement 31 · standardAP
2023-12-07Labeling · Supplement 28 · standardAP
2023-12-07Labeling · Supplement 26 · standardAP
2023-12-07Labeling · Supplement 16 · standardAP
2023-12-07Labeling · Supplement 20 · standardAP
2023-12-07Labeling · Supplement 19 · standardAP
2023-12-07Labeling · Supplement 23 · standardAP
2023-12-07Labeling · Supplement 15 · standardAP
2018-09-18REMS · Supplement 17AP
2015-11-09Labeling · Supplement 11 · standardAP
2010-11-22Labeling · Supplement 5AP
2005-04-08Labeling · Supplement 3AP
2002-10-30Labeling · 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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