APPLICATION
NDA018557
TYPE
NDA
ORIGINAL APPROVAL
1981-10-28
LATEST ACTION
2004-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FANSIDARDiscontinued
PYRIMETHAMINE 25MG, SULFADOXINE 500MG · TABLET · ORAL
Approval history
1998-08-14Manufacturing (CMC) · Supplement 14 · priorityAP
1993-06-09Manufacturing (CMC) · Supplement 13 · priorityAP
1987-11-03Labeling · Supplement 12 · priorityAP
1987-04-30Labeling · Supplement 11 · priorityAP
1985-07-24Labeling · Supplement 7 · priorityAP
1985-07-24Labeling · Supplement 10 · priorityAP
1985-07-24Labeling · Supplement 8 · priorityAP
1985-07-24Labeling · Supplement 9 · priorityAP
1983-10-26Manufacturing (CMC) · Supplement 6 · priorityAP
1983-07-26Manufacturing (CMC) · Supplement 5 · priorityAP
1983-07-21Manufacturing (CMC) · Supplement 3 · priorityAP
1983-07-21Manufacturing (CMC) · Supplement 2 · priorityAP
1981-10-28Type 1 - New Molecular Entity and Type 4 - New Combination · 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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