APPLICATION
ANDA209404
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 200MG · TABLET, EXTENDED RELEASE · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 300MG · TABLET, EXTENDED RELEASE · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-06-18REMS · Supplement 3AP
2025-12-29Labeling · Supplement 2 · standardAP
2025-01-31UNKNOWN · Original · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.