APPLICATION
NDA018590
TYPE
NDA
ORIGINAL APPROVAL
1982-10-29
LATEST ACTION
1999-09-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOCAPROIC ACIDDiscontinued
AMINOCAPROIC ACID 250MG/ML · INJECTABLE · INJECTION
Approval history
1999-09-09Labeling · Supplement 17AP
1998-10-22Manufacturing (CMC) · Supplement 16AP
1997-09-16Manufacturing (CMC) · Supplement 15AP
1992-07-06Labeling · Supplement 13AP
1992-05-19Manufacturing (CMC) · Supplement 14AP
1987-09-25Manufacturing (CMC) · Supplement 9AP
1986-11-03Manufacturing (CMC) · Supplement 11AP
1982-10-29OriginalAP
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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