APPLICATION
NDA016000
TYPE
NDA
ORIGINAL APPROVAL
1966-07-01
LATEST ACTION
1981-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SULLADiscontinued
SULFAMETER 500MG · TABLET · ORAL
Approval history
1981-01-16Manufacturing (CMC) · Supplement 15 · standardAP
1980-06-30Labeling · Supplement 14 · standardAP
1980-06-27Manufacturing (CMC) · Supplement 13 · standardAP
1980-01-14Labeling · Supplement 12 · standardAP
1979-02-13Manufacturing (CMC) · Supplement 9 · standardAP
1979-01-10Labeling · Supplement 10 · standardAP
1978-01-12Manufacturing (CMC) · Supplement 8 · standardAP
1977-08-11Manufacturing (CMC) · Supplement 7 · standardAP
1977-08-09Manufacturing (CMC) · Supplement 6 · standardAP
1976-11-22Manufacturing (CMC) · Supplement 4 · standardAP
1976-04-28Manufacturing (CMC) · Supplement 3 · standardAP
1975-11-13Supplement · Supplement 1 · standardAP
1975-05-23Manufacturing (CMC) · Supplement 2 · standardAP
1966-07-01Type 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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