← FDA DRUG APPROVALS

FDA ANDA · ANDA089859

CHLORZOXAZONE

Sponsor: WATSON LABS

APPLICATION
ANDA089859
TYPE
ANDA
ORIGINAL APPROVAL
1988-05-04
LATEST ACTION
2001-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CHLORZOXAZONEPrescription
CHLORZOXAZONE 500MG · TABLET · ORAL

Approval history

2001-08-30Manufacturing (CMC) · Supplement 31AP
2000-07-07Manufacturing (CMC) · Supplement 30AP
1999-11-19Manufacturing (CMC) · Supplement 29AP
1998-03-09Manufacturing (CMC) · Supplement 28AP
1997-10-17Manufacturing (CMC) · Supplement 27AP
1997-01-07Manufacturing (CMC) · Supplement 25AP
1996-12-13Manufacturing (CMC) · Supplement 26AP
1996-08-08Manufacturing (CMC) · Supplement 3AP
1995-10-03Manufacturing (CMC) · Supplement 23AP
1995-10-03Manufacturing (CMC) · Supplement 21AP
1995-10-03Manufacturing (CMC) · Supplement 22AP
1995-09-20Labeling · Supplement 24AP
1995-03-02Manufacturing (CMC) · Supplement 20AP
1994-01-26Manufacturing (CMC) · Supplement 19AP
1994-01-26Manufacturing (CMC) · Supplement 17AP
1994-01-26Manufacturing (CMC) · Supplement 15AP
1994-01-26Manufacturing (CMC) · Supplement 13AP
1994-01-26Manufacturing (CMC) · Supplement 11AP
1994-01-26Manufacturing (CMC) · Supplement 18AP
1994-01-26Manufacturing (CMC) · Supplement 16AP
1994-01-26Manufacturing (CMC) · Supplement 14AP
1994-01-26Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 10AP
1993-05-25Manufacturing (CMC) · Supplement 8AP
1993-05-25Manufacturing (CMC) · Supplement 7AP
1993-04-01Manufacturing (CMC) · Supplement 6AP
1993-04-01Manufacturing (CMC) · Supplement 9AP
1992-12-30Manufacturing (CMC) · Supplement 4AP
1992-09-25Labeling · Supplement 5AP
1991-12-09Manufacturing (CMC) · Supplement 2AP
1991-12-09Manufacturing (CMC) · Supplement 1AP
1988-05-04OriginalAP
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 →