APPLICATION
ANDA210543
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-06
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
Approval history
2025-06-13Labeling · Supplement 3 · standardAP
2022-07-07Labeling · Supplement 1 · standardAP
2022-07-07Labeling · Supplement 2 · 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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