APPLICATION
ANDA075968
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-25
LATEST ACTION
2026-07-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 100MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 25MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2026-07-28Manufacturing (CMC) · Supplement 18 · unknownAP
2026-06-18REMS · Supplement 23AP
2025-12-23Labeling · Supplement 21 · standardAP
2024-10-31REMS · Supplement 15AP
2024-08-02Manufacturing (CMC) · Supplement 14 · unknownAP
2024-05-28Manufacturing (CMC) · Supplement 12 · unknownAP
2024-02-01Labeling · Supplement 13 · standardAP
2018-09-18REMS · Supplement 11AP
2015-05-11Labeling · Supplement 10 · standardAP
2015-05-11Labeling · Supplement 9 · standardAP
2002-10-30Labeling · 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.
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.