APPLICATION
ANDA089624
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-13
LATEST ACTION
1999-06-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
REVERSOLDiscontinued
EDROPHONIUM CHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
1999-06-09Manufacturing (CMC) · Supplement 8AP
1996-03-27Manufacturing (CMC) · Supplement 6AP
1996-01-23Manufacturing (CMC) · Supplement 7AP
1994-03-07Manufacturing (CMC) · Supplement 5AP
1993-11-04Labeling · Supplement 4AP
1992-05-08Manufacturing (CMC) · Supplement 3AP
1992-02-06Manufacturing (CMC) · Supplement 2AP
1988-05-13OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.