APPLICATION
ANDA214330
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-08
LATEST ACTION
2025-02-03
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
SULFAMETHOXAZOLE AND TRIMETHOPRIMPrescription
SULFAMETHOXAZOLE 200MG/5ML, TRIMETHOPRIM 40MG/5ML · SUSPENSION · ORAL
Approval history
2025-02-03Labeling · Supplement 11 · standardAP
2024-06-24Labeling · Supplement 8 · standardAP
2022-02-08UNKNOWN · 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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