APPLICATION
NDA018374
TYPE
NDA
ORIGINAL APPROVAL
1981-06-23
LATEST ACTION
2025-02-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BACTRIM · ReferenceDiscontinued
SULFAMETHOXAZOLE 80MG/ML, TRIMETHOPRIM 16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-09-13Manufacturing (CMC) · Supplement 24 · priorityAP
1997-10-21Manufacturing (CMC) · Supplement 22 · priorityAP
1997-08-19Manufacturing (CMC) · Supplement 21 · priorityAP
1996-03-06Labeling · Supplement 15AP
1992-06-23Manufacturing (CMC) · Supplement 19 · priorityAP
1991-11-05Manufacturing (CMC) · Supplement 20 · priorityAP
1987-11-03Manufacturing (CMC) · Supplement 17 · priorityAP
1987-11-02Labeling · Supplement 11AP
1987-08-11Labeling · Supplement 14AP
1985-08-05Manufacturing (CMC) · Supplement 13 · priorityAP
1985-07-22Manufacturing (CMC) · Supplement 12 · priorityAP
1984-11-23Labeling · Supplement 10AP
1984-04-02Manufacturing (CMC) · Supplement 9 · priorityAP
1983-03-30Manufacturing (CMC) · Supplement 7 · priorityAP
1983-03-30Manufacturing (CMC) · Supplement 8 · priorityAP
1982-09-24Manufacturing (CMC) · Supplement 5 · priorityAP
1982-05-13Manufacturing (CMC) · Supplement 3 · priorityAP
1981-09-28Manufacturing (CMC) · Supplement 1 · priorityAP
1981-09-28Manufacturing (CMC) · Supplement 2 · priorityAP
1981-06-23Type 3 - New Dosage Form · 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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