APPLICATION
NDA017952
TYPE
NDA
ORIGINAL APPROVAL
1980-05-30
LATEST ACTION
1997-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIMPEX 200Discontinued
TRIMETHOPRIM 200MG · TABLET · ORAL
TRIMPEXDiscontinued
TRIMETHOPRIM 100MG · TABLET · ORAL
Approval history
1997-07-31Manufacturing (CMC) · Supplement 14 · standardAP
1990-07-17Manufacturing (CMC) · Supplement 13 · standardAP
1989-04-20Manufacturing (CMC) · Supplement 12 · standardAP
1983-08-01Manufacturing (CMC) · Supplement 9 · standardAP
1983-08-01Manufacturing (CMC) · Supplement 8 · standardAP
1983-07-11Labeling · Supplement 5 · standardAP
1983-01-26Manufacturing (CMC) · Supplement 7 · standardAP
1982-11-09Manufacturing (CMC) · Supplement 6 · standardAP
1982-07-08Labeling · Supplement 2 · standardAP
1981-10-09Manufacturing (CMC) · Supplement 4 · standardAP
1981-04-23Manufacturing (CMC) · Supplement 3 · standardAP
1980-10-28Manufacturing (CMC) · Supplement 1 · standardAP
1980-05-30Type 5 - New Formulation or New Manufacturer · 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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