APPLICATION
ANDA090404
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-31
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 22AP
2025-12-31Labeling · Supplement 19 · standardAP
2025-12-31Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 20AP
2023-12-15Labeling · Supplement 18 · standardAP
2023-12-15Labeling · Supplement 17 · standardAP
2023-11-07Labeling · Supplement 16 · standardAP
2023-11-07Labeling · Supplement 14 · standardAP
2023-11-07Labeling · Supplement 5 · standardAP
2023-11-07Labeling · Supplement 12 · standardAP
2023-11-07Labeling · Supplement 10 · standardAP
2023-11-07Labeling · Supplement 6 · standardAP
2018-09-18REMS · Supplement 8AP
2015-11-09Labeling · Supplement 3 · standardAP
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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