APPLICATION
NDA018689
TYPE
NDA
ORIGINAL APPROVAL
1985-05-24
LATEST ACTION
2013-05-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RIDAURA · ReferencePrescription
AURANOFIN 3MG · CAPSULE · ORAL
Approval history
2013-05-14Manufacturing (CMC) · Supplement 18 · priorityAP
2002-05-23Manufacturing (CMC) · Supplement 16 · priorityAP
1999-12-22Manufacturing (CMC) · Supplement 14 · priorityAP
1999-12-22Labeling · Supplement 15 · standardAP
1998-04-23Labeling · Supplement 12AP
1998-04-23Labeling · Supplement 11AP
1996-01-02Manufacturing (CMC) · Supplement 13 · priorityAP
1989-04-13Labeling · Supplement 10AP
1987-11-02Labeling · Supplement 7AP
1987-11-02Labeling · Supplement 8AP
1987-04-27Labeling · Supplement 6AP
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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