APPLICATION
ANDA070010
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-09
LATEST ACTION
2007-02-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
AMINOCAPROIC ACID IN PLASTIC CONTAINERPrescription
AMINOCAPROIC ACID 250MG/ML · INJECTABLE · INJECTION
Approval history
2007-02-27Labeling · Supplement 16AP
2002-11-15Labeling · Supplement 13AP
2001-02-15Manufacturing (CMC) · Supplement 12AP
1999-10-20Manufacturing (CMC) · Supplement 9AP
1999-10-20Labeling · Supplement 10AP
1999-06-08Labeling · Supplement 11AP
1998-09-08Labeling · Supplement 8AP
1996-10-22Manufacturing (CMC) · Supplement 6AP
1996-10-03Manufacturing (CMC) · Supplement 7AP
1995-01-26Manufacturing (CMC) · Supplement 4AP
1994-07-27Manufacturing (CMC) · Supplement 3AP
1993-05-21Labeling · Supplement 2AP
1991-12-03Labeling · Supplement 1AP
1987-03-09OriginalAP
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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