APPLICATION
NDA009768
TYPE
NDA
ORIGINAL APPROVAL
1955-04-18
LATEST ACTION
2023-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PLAQUENIL · ReferencePrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL
Approval history
2002-05-02Manufacturing (CMC) · Supplement 35 · standardAP
2002-02-07Manufacturing (CMC) · Supplement 34 · standardAP
2000-10-05Labeling · Supplement 33 · standardAP
1996-10-02Manufacturing (CMC) · Supplement 32 · standardAP
1994-05-26Labeling · Supplement 29AP
1991-02-14Manufacturing (CMC) · Supplement 27 · standardAP
1991-02-14Manufacturing (CMC) · Supplement 28 · standardAP
1990-11-19Manufacturing (CMC) · Supplement 26 · standardAP
1989-04-04Manufacturing (CMC) · Supplement 25 · standardAP
1988-09-30Manufacturing (CMC) · Supplement 24 · standardAP
1988-08-04Manufacturing (CMC) · Supplement 23 · standardAP
1987-03-03Labeling · Supplement 17AP
1987-01-02Labeling · Supplement 11AP
1986-12-12Manufacturing (CMC) · Supplement 22 · standardAP
1985-07-22Manufacturing (CMC) · Supplement 20 · standardAP
1985-07-05Manufacturing (CMC) · Supplement 18 · standardAP
1984-11-01Manufacturing (CMC) · Supplement 16 · standardAP
1983-06-17Manufacturing (CMC) · Supplement 15 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 14 · standardAP
1982-06-30Manufacturing (CMC) · Supplement 13 · standardAP
1982-05-14Manufacturing (CMC) · Supplement 12 · standardAP
1981-05-15Manufacturing (CMC) · Supplement 10 · standardAP
1980-02-19Labeling · Supplement 9AP
1976-04-29Labeling · Supplement 7AP
1955-04-18Type 1 - New Molecular Entity · 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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