APPLICATION
ANDA206607
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-30
LATEST ACTION
2025-02-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 80MG/ML, TRIMETHOPRIM 16MG/ML · INJECTABLE · INJECTION
Approval history
2025-02-21Labeling · Supplement 11 · standardAP
2022-09-22Labeling · Supplement 6 · standardAP
2022-09-22Labeling · Supplement 4 · standardAP
2022-09-22Labeling · Supplement 1 · standardAP
2017-08-30UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.