APPLICATION
ANDA202075
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 14AP
2026-03-23Manufacturing (CMC) · Supplement 9 · unknownAP
2026-02-12Manufacturing (CMC) · Supplement 7 · standardAP
2025-12-23Labeling · Supplement 8 · standardAP
2024-10-31REMS · Supplement 6AP
2023-12-21Labeling · Supplement 5 · standardAP
2022-06-28Labeling · Supplement 4 · standardAP
2019-06-14REMS · Supplement 2AP
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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