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FDA NDA · NDA015197

AMINOCAPROIC ACID

Sponsor: HIKMA

APPLICATION
NDA015197
TYPE
NDA
ORIGINAL APPROVAL
1964-06-03
LATEST ACTION
2008-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMICAR · ReferencePrescription
AMINOCAPROIC ACID 500MG · TABLET · ORAL
AMICAR · ReferencePrescription
AMINOCAPROIC ACID 1GM · TABLET · ORAL

Approval history

2008-08-19Labeling · Supplement 43 · standard — Label ↗AP
2004-08-24Labeling · Supplement 40 · standard — Letter ↗AP
2004-06-24Manufacturing (CMC) · Supplement 39 · priority — Letter ↗AP
2004-06-24Manufacturing (CMC) · Supplement 37 · priority — Letter ↗AP
2004-06-24Manufacturing (CMC) · Supplement 38 · priority — Label ↗AP
2004-06-24Manufacturing (CMC) · Supplement 36 · priority — Label ↗AP
2000-11-27Manufacturing (CMC) · Supplement 35 · priorityAP
2000-10-02Manufacturing (CMC) · Supplement 33 · priorityAP
2000-04-03Labeling · Supplement 34 · standardAP
1999-10-01Manufacturing (CMC) · Supplement 32 · priorityAP
1997-04-16Labeling · Supplement 30 · standardAP
1992-08-13Manufacturing (CMC) · Supplement 28 · priorityAP
1992-02-11Manufacturing (CMC) · Supplement 29 · priorityAP
1990-04-03Labeling · Supplement 23AP
1986-01-17Labeling · Supplement 27AP
1983-06-06Labeling · Supplement 26AP
1982-12-10Labeling · Supplement 25AP
1982-10-22Manufacturing (CMC) · Supplement 22 · priorityAP
1982-09-22Manufacturing (CMC) · Supplement 24 · priorityAP
1981-06-30Manufacturing (CMC) · Supplement 19 · priorityAP
1977-02-09Manufacturing (CMC) · Supplement 15 · priorityAP
1964-06-03Type 1 - New Molecular Entity · 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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