APPLICATION
ANDA210441
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-01
LATEST ACTION
2024-10-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 400MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 100MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 300MG · TABLET · ORAL
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
Approval history
2024-10-08Labeling · Supplement 15 · standardAP
2023-11-29Labeling · Supplement 13 · standardAP
2022-09-19Manufacturing (CMC) · Supplement 10 · unknownAP
2022-07-07Labeling · Supplement 12 · standardAP
2022-04-27Labeling · Supplement 8 · 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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