← FDA DRUG APPROVALS

FDA NDA · NDA214044

TRAMADOL HYDROCHLORIDE

Sponsor: ROSEMONT

APPLICATION
NDA214044
TYPE
NDA
ORIGINAL APPROVAL
2020-09-01
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

QDOLO · ReferenceDiscontinued
TRAMADOL HYDROCHLORIDE 5MG/ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 5 — Letter ↗AP
2025-12-22Labeling · Supplement 4 · standard — Letter ↗AP
2024-10-31REMS · Supplement 3 — Letter ↗AP
2023-12-15Labeling · Supplement 2 · standard — Label ↗AP
2021-09-10Labeling · Supplement 1 · standard — Label ↗AP
2020-09-01Type 3 - New Dosage Form · Original · standard — Label ↗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 →