APPLICATION
ANDA088873
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-06
LATEST ACTION
2011-01-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ENLONDiscontinued
EDROPHONIUM CHLORIDE 10MG/ML · INJECTABLE · INJECTION
Approval history
2011-01-10Manufacturing (CMC) · Supplement 23AP
2009-09-28Labeling · Supplement 22AP
2009-04-03Labeling · Supplement 19AP
2001-02-20Manufacturing (CMC) · Supplement 15AP
2001-02-20Manufacturing (CMC) · Supplement 16AP
2000-07-11Manufacturing (CMC) · Supplement 13AP
2000-07-11Manufacturing (CMC) · Supplement 14AP
1991-11-22Labeling · Supplement 25AP
1991-11-22Labeling · Supplement 12AP
1991-02-07Manufacturing (CMC) · Supplement 10AP
1987-09-03Manufacturing (CMC) · Supplement 5AP
1986-05-15Manufacturing (CMC) · Supplement 1AP
1986-05-15Manufacturing (CMC) · Supplement 2AP
1985-08-06OriginalAP
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.
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