APPLICATION
ANDA074650
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-29
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMDiscontinued
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
Approval history
2025-02-21Labeling · Supplement 24 · standardAP
2024-06-24Labeling · Supplement 22 · standardAP
2022-07-06Labeling · Supplement 19 · standardAP
2014-12-24Manufacturing (CMC) · Supplement 12AP
2009-09-15Labeling · Supplement 8AP
2000-04-21Manufacturing (CMC) · Supplement 4AP
2000-01-24Manufacturing (CMC) · Supplement 1AP
2000-01-24Labeling · Supplement 2AP
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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