APPLICATION
ANDA076003
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-20
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 65AP
2025-12-22Labeling · Supplement 61 · standardAP
2025-10-24Labeling · Supplement 57 · standardAP
2024-10-31REMS · Supplement 58AP
2024-01-05Labeling · Supplement 56 · standardAP
2023-11-18Labeling · Supplement 55 · standardAP
2023-02-07Manufacturing (CMC) · Supplement 50 · unknownAP
2022-09-21Labeling · Supplement 33 · standardAP
2022-09-21Labeling · Supplement 48 · standardAP
2022-09-21Labeling · Supplement 38 · standardAP
2022-09-21Labeling · Supplement 40 · standardAP
2022-09-21Labeling · Supplement 49 · standardAP
2022-09-21Labeling · Supplement 39 · standardAP
2022-09-21Labeling · Supplement 43 · standardAP
2022-09-21Labeling · Supplement 35 · standardAP
2018-09-18REMS · Supplement 37AP
2015-04-16Labeling · Supplement 13AP
2015-04-16Labeling · Supplement 30 · standardAP
2013-09-27Manufacturing (CMC) · Supplement 18AP
2011-09-30Labeling · Supplement 22AP
2004-07-26Labeling · Supplement 4AP
2002-10-29Labeling · Supplement 2AP
2002-07-18Manufacturing (CMC) · 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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