← FDA DRUG APPROVALS

FDA NDA · NDA015230

AMINOCAPROIC ACID

Sponsor: HIKMA

APPLICATION
NDA015230
TYPE
NDA
ORIGINAL APPROVAL
1964-06-04
LATEST ACTION
2009-02-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AMICAR · ReferencePrescription
AMINOCAPROIC ACID 0.25GM/ML · SOLUTION · ORAL

Approval history

2009-02-03Labeling · Supplement 37 · standard — Label ↗AP
2008-08-19Labeling · Supplement 35 · standard — Letter ↗AP
2004-08-24Labeling · Supplement 31 · standard — Letter ↗AP
2003-09-02Manufacturing (CMC) · Supplement 28 · priority — Letter ↗AP
2003-09-02Manufacturing (CMC) · Supplement 30 · priority — Letter ↗AP
2003-09-02Manufacturing (CMC) · Supplement 29 · priority — Letter ↗AP
1999-09-14Manufacturing (CMC) · Supplement 26 · priorityAP
1999-09-14Manufacturing (CMC) · Supplement 27 · priorityAP
1999-09-14Manufacturing (CMC) · Supplement 25 · priorityAP
1997-04-16Labeling · Supplement 23 · standardAP
1997-01-17Manufacturing (CMC) · Supplement 24 · priorityAP
1990-04-03Labeling · Supplement 17AP
1986-11-04Manufacturing (CMC) · Supplement 22 · priorityAP
1986-01-17Labeling · Supplement 21AP
1983-06-06Labeling · Supplement 20AP
1982-12-10Labeling · Supplement 19AP
1982-09-22Manufacturing (CMC) · Supplement 18 · priorityAP
1980-12-22Manufacturing (CMC) · Supplement 15 · priorityAP
1978-10-17Manufacturing (CMC) · Supplement 12 · priorityAP
1964-06-04Type 3 - New Dosage Form · Original · priorityAP
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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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