← FDA DRUG APPROVALS

FDA ANDA · ANDA040133

HYDROXYCHLOROQUINE SULFATE

Sponsor: WATSON LABS

APPLICATION
ANDA040133
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-30
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROXYCHLOROQUINE SULFATEDiscontinued
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

Approval history

2024-07-11Labeling · Supplement 34 · standardAP
2024-07-11Labeling · Supplement 32 · standardAP
2024-07-11Labeling · Supplement 33 · standardAP
2022-04-06Labeling · Supplement 31 · standardAP
2020-04-01Labeling · Supplement 30 · standard — Label ↗AP
2020-04-01Labeling · Supplement 29 · standard — Label ↗AP
2003-11-21Labeling · Supplement 13AP
2001-04-12Manufacturing (CMC) · Supplement 9AP
2000-03-21Manufacturing (CMC) · Supplement 7AP
1998-08-19Manufacturing (CMC) · Supplement 6AP
1998-02-23Manufacturing (CMC) · Supplement 4AP
1998-02-23Manufacturing (CMC) · Supplement 5AP
1997-10-07Manufacturing (CMC) · Supplement 1AP
1997-07-08Manufacturing (CMC) · Supplement 2AP
1995-11-30OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →