← FDA DRUG APPROVALS

FDA ANDA · ANDA040150

HYDROXYCHLOROQUINE SULFATE

Sponsor: CREEKWOOD PHARMS

APPLICATION
ANDA040150
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-27
LATEST ACTION
2020-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROXYCHLOROQUINE SULFATEPrescription
HYDROXYCHLOROQUINE SULFATE 200MG · TABLET · ORAL

Approval history

2020-04-01Labeling · Supplement 7 · standard — Label ↗AP
2001-03-20Manufacturing (CMC) · Supplement 6AP
2001-03-20Manufacturing (CMC) · Supplement 5AP
2000-02-09Manufacturing (CMC) · Supplement 4AP
1999-02-04Manufacturing (CMC) · Supplement 3AP
1996-09-10Manufacturing (CMC) · Supplement 2AP
1996-09-10Manufacturing (CMC) · Supplement 1AP
1996-01-27OriginalAP
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 →