APPLICATION
ANDA212231
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-26
LATEST ACTION
2025-02-21
ROUTE
INTRAVENOUS, 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 12 · standardAP
2022-09-22Labeling · Supplement 2 · standardAP
2022-09-22Labeling · Supplement 5 · standardAP
2019-06-26UNKNOWN · 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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