APPLICATION
ANDA040104
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-30
LATEST ACTION
2024-09-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
Approval history
2024-09-05Labeling · Supplement 37 · standardAP
2024-09-05Labeling · Supplement 38 · standardAP
2024-09-05Labeling · Supplement 36 · standardAP
2021-08-23Labeling · Supplement 35 · standardAP
2007-11-28Labeling · Supplement 15AP
2002-04-19Manufacturing (CMC) · Supplement 10AP
2001-05-09Manufacturing (CMC) · Supplement 9AP
2001-03-13Manufacturing (CMC) · Supplement 8AP
2000-02-17Manufacturing (CMC) · Supplement 7AP
1999-08-20Manufacturing (CMC) · Supplement 6AP
1999-02-11Manufacturing (CMC) · Supplement 5AP
1997-05-05Manufacturing (CMC) · Supplement 3AP
1997-03-25Manufacturing (CMC) · Supplement 4AP
1996-05-15Manufacturing (CMC) · Supplement 2AP
1996-05-15Manufacturing (CMC) · Supplement 1AP
1995-11-30OriginalAP
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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