APPLICATION
ANDA071192
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-01
LATEST ACTION
2007-02-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMINOCAPROIC ACIDPrescription
AMINOCAPROIC ACID 250MG/ML · INJECTABLE · INJECTION
Approval history
2007-02-26Labeling · Supplement 12AP
2000-02-04Labeling · Supplement 7AP
1999-10-19Labeling · Supplement 6AP
1997-08-28Manufacturing (CMC) · Supplement 5AP
1996-02-28Manufacturing (CMC) · Supplement 4AP
1994-06-28Manufacturing (CMC) · Supplement 3AP
1991-12-03Labeling · Supplement 2AP
1991-08-01Manufacturing (CMC) · Supplement 1AP
1987-12-01OriginalAP
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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