← FDA DRUG APPROVALS

FDA NDA · NDA020315

ORLAAM

Sponsor: ROXANE

APPLICATION
NDA020315
TYPE
NDA
ORIGINAL APPROVAL
1993-07-09
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

ORLAAM · ReferenceDiscontinued
LEVOMETHADYL ACETATE HYDROCHLORIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL

Approval history

2007-12-07Labeling · Supplement 10 · standardAP
2001-05-17Labeling · Supplement 9 · standardAP
2001-03-30Labeling · Supplement 6 · standard — Letter ↗AP
2001-03-01Manufacturing (CMC) · Supplement 7 · priorityAP
1998-07-02Manufacturing (CMC) · Supplement 5 · priorityAP
1997-08-08Manufacturing (CMC) · Supplement 3 · priorityAP
1997-07-16Manufacturing (CMC) · Supplement 2 · priorityAP
1996-12-27Manufacturing (CMC) · Supplement 1 · priorityAP
1996-12-27Manufacturing (CMC) · Supplement 4 · priorityAP
1993-07-09Type 1 - New Molecular Entity · Original · priorityAP
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 →