APPLICATION
ANDA212902
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-14
LATEST ACTION
2023-10-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
Approval history
2023-10-05Labeling · Supplement 4 · standardAP
2023-10-05Labeling · Supplement 5 · standardAP
2023-10-05Labeling · Supplement 3 · standardAP
2020-05-14UNKNOWN · 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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