APPLICATION
ANDA074759
TYPE
ANDA
ORIGINAL APPROVAL
1998-09-02
LATEST ACTION
2010-08-31
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
AMINOCAPROIC ACIDDiscontinued
AMINOCAPROIC ACID 0.25GM/ML · SOLUTION · ORAL
Approval history
2010-08-31Labeling · Supplement 10AP
2010-08-31Labeling · Supplement 11AP
2002-08-13Manufacturing (CMC) · Supplement 3AP
2002-04-23Manufacturing (CMC) · Supplement 1AP
2002-04-23Manufacturing (CMC) · Supplement 2AP
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.