APPLICATION
NDA015229
TYPE
NDA
ORIGINAL APPROVAL
1964-06-08
LATEST ACTION
2004-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
AMICAR · ReferenceDiscontinued
AMINOCAPROIC ACID 250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-04-03Labeling · Supplement 30 · standardAP
1999-10-01Manufacturing (CMC) · Supplement 29 · priorityAP
1997-04-16Labeling · Supplement 28 · standardAP
1995-05-19Manufacturing (CMC) · Supplement 25 · priorityAP
1995-03-07Manufacturing (CMC) · Supplement 27 · priorityAP
1994-11-01Manufacturing (CMC) · Supplement 26 · priorityAP
1990-04-03Labeling · Supplement 18AP
1986-01-17Labeling · Supplement 24AP
1983-12-05Efficacy · Supplement 22AP
1983-06-06Labeling · Supplement 21AP
1982-12-10Labeling · Supplement 20AP
1982-09-22Manufacturing (CMC) · Supplement 19 · priorityAP
1979-10-10Labeling · Supplement 15AP
1979-09-07Manufacturing (CMC) · Supplement 16 · priorityAP
1977-12-14Manufacturing (CMC) · Supplement 14 · priorityAP
1977-09-14Manufacturing (CMC) · Supplement 13 · priorityAP
1977-09-14Manufacturing (CMC) · Supplement 12 · priorityAP
1977-03-10Manufacturing (CMC) · Supplement 11 · priorityAP
1964-06-08Type 3 - New Dosage Form · Original · priorityAP
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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