← FDA DRUG APPROVALS

FDA NDA · NDA019678

ENLON-PLUS

Sponsor: PHARMOBEDIENT

APPLICATION
NDA019678
TYPE
NDA
ORIGINAL APPROVAL
1991-11-06
LATEST ACTION
2025-10-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ENLON-PLUS · ReferenceDiscontinued
ATROPINE SULFATE 0.14MG/ML, EDROPHONIUM CHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-10-28Labeling · Supplement 10 · standard — Label ↗AP
2005-12-06Labeling · Supplement 5 · standard — Letter ↗AP
2002-04-18Manufacturing (CMC) · Supplement 4 · standardAP
2000-12-26Manufacturing (CMC) · Supplement 3 · standardAP
1994-04-20Manufacturing (CMC) · Supplement 2 · standardAP
1992-03-20Manufacturing (CMC) · Supplement 1 · standardAP
1991-11-06Type 5 - New Formulation or New Manufacturer · Original · standardAP
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 →