APPLICATION
NDA008565
TYPE
NDA
ORIGINAL APPROVAL
1953-10-28
LATEST ACTION
1988-10-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THIOSULFILDiscontinued
SULFAMETHIZOLE 500MG · TABLET · ORAL
THIOSULFILDiscontinued
SULFAMETHIZOLE 250MG · TABLET · ORAL
Approval history
1988-10-17Labeling · Supplement 21 · standardAP
1987-12-30Manufacturing (CMC) · Supplement 20 · standardAP
1980-06-26Manufacturing (CMC) · Supplement 13 · standardAP
1980-04-17Manufacturing (CMC) · Supplement 14 · standardAP
1979-03-16Manufacturing (CMC) · Supplement 12 · standardAP
1978-09-22Manufacturing (CMC) · Supplement 11 · standardAP
1978-06-01Labeling · Supplement 9 · standardAP
1978-01-31Manufacturing (CMC) · Supplement 10 · standardAP
1977-07-25Manufacturing (CMC) · Supplement 8 · standardAP
1976-12-23Manufacturing (CMC) · Supplement 7 · standardAP
1976-01-20Manufacturing (CMC) · Supplement 6 · standardAP
1975-03-26Manufacturing (CMC) · Supplement 3 · standardAP
1974-11-04Manufacturing (CMC) · Supplement 4 · standardAP
1974-11-04Manufacturing (CMC) · Supplement 5 · standardAP
1953-10-28Type 1 - New Molecular Entity · Original · standardAP
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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