← FDA DRUG APPROVALS

FDA ANDA · ANDA202390

TRAMADOL HYDROCHLORIDE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA202390
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-16
LATEST ACTION
2015-10-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRAMADOL HYDROCHLORIDEDiscontinued
TRAMADOL HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2015-10-26Labeling · Supplement 1 · standardAP
2013-05-16UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →