← FDA DRUG APPROVALS

FDA ANDA · ANDA208708

TRAMADOL HYDROCHLORIDE

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA208708
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-28
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 75MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 100MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 25MG · TABLET · ORAL
TRAMADOL HYDROCHLORIDEPrescription
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 25AP
2025-12-23Labeling · Supplement 22 · standardAP
2025-09-03Manufacturing (CMC) · Supplement 21 · unknown — Letter ↗AP
2025-07-01Labeling · Supplement 17 · standardAP
2024-10-31REMS · Supplement 18AP
2024-04-04Manufacturing (CMC) · Supplement 16 · unknown — Review ↗AP
2023-12-15Labeling · Supplement 11 · standardAP
2023-11-27Manufacturing (CMC) · Supplement 13 · unknownAP
2023-10-06Labeling · Supplement 7 · standardAP
2023-10-06Labeling · Supplement 6 · standardAP
2021-01-13Labeling · Supplement 1 · standardAP
2021-01-13Labeling · Supplement 2 · standardAP
2019-06-28UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →