← FDA DRUG APPROVALS

FDA NDA · NDA022396

DYLOJECT

Sponsor: JAVELIN PHARMS INC

APPLICATION
NDA022396
TYPE
NDA
ORIGINAL APPROVAL
2014-12-23
LATEST ACTION
2016-05-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

DYLOJECT · ReferenceDiscontinued
DICLOFENAC SODIUM 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2016-05-09Labeling · Supplement 3 · standard — Label ↗AP
2015-07-15Manufacturing (CMC) · Supplement 1 · standardAP
2015-05-27Manufacturing (CMC) · Supplement 2 · standardAP
2014-12-23Type 3 - New Dosage Form · Original · standard — Review ↗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 →