APPLICATION
ANDA077612
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-13
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
Approval history
2025-02-21Labeling · Supplement 19 · standardAP
2024-06-24Labeling · Supplement 18 · standardAP
2023-09-12Labeling · Supplement 14 · standardAP
2021-10-25Manufacturing (CMC) · Supplement 6 · unknownAP
2007-11-01Labeling · Supplement 2AP
2007-05-31Labeling · Supplement 1AP
2006-11-13OriginalAP
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.