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FDA ANDA · ANDA077785
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Sponsor: CHARTWELL MOLECULAR
APPLICATION
ANDA077785
TYPE
ANDA
ORIGINAL APPROVAL
2007-01-24
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 18 · standardAP
2024-06-24Labeling · Supplement 17 · standardAP
2022-09-22Labeling · Supplement 16 · standardAP
2022-09-22Labeling · Supplement 13 · standardAP
2011-06-23Labeling · Supplement 7AP
2008-09-03Labeling · Supplement 1AP
2007-01-24OriginalAP
2007-01-24OriginalAP
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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