APPLICATION
ANDA212699
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-05
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 3 · standardAP
2024-06-24Labeling · Supplement 2 · standardAP
2022-05-24Labeling · Supplement 1 · standardAP
2021-01-05UNKNOWN · 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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