APPLICATION
ANDA075964
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 48AP
2025-12-22Labeling · Supplement 47 · standardAP
2025-12-15Labeling · Supplement 45 · standardAP
2024-10-31REMS · Supplement 46AP
2024-01-10Labeling · Supplement 43 · standardAP
2022-09-06Labeling · Supplement 29 · standardAP
2022-09-06Labeling · Supplement 35 · standardAP
2022-09-06Labeling · Supplement 27 · standardAP
2022-09-06Labeling · Supplement 41 · standardAP
2022-09-06Labeling · Supplement 36 · standardAP
2022-09-06Labeling · Supplement 42 · standardAP
2022-09-06Labeling · Supplement 32 · standardAP
2018-09-18REMS · Supplement 31AP
2015-10-15Labeling · Supplement 25 · standardAP
2010-11-22Labeling · Supplement 16AP
2003-06-16Labeling · Supplement 2AP
2002-09-27Labeling · Supplement 5AP
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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