APPLICATION
ANDA070888
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-16
LATEST ACTION
1995-05-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMINOCAPROIC ACIDDiscontinued
AMINOCAPROIC ACID 250MG/ML · INJECTABLE · INJECTION
Approval history
1995-05-10Manufacturing (CMC) · Supplement 10AP
1994-01-06Labeling · Supplement 9AP
1992-10-30Manufacturing (CMC) · Supplement 8AP
1992-02-24Labeling · Supplement 6AP
1991-06-17Manufacturing (CMC) · Supplement 5AP
1991-06-17Manufacturing (CMC) · Supplement 3AP
1991-06-17Manufacturing (CMC) · Supplement 4AP
1988-06-16OriginalAP
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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