← FDA DRUG APPROVALS

FDA ANDA · ANDA084279

PROBENECID AND COLCHICINE

Sponsor: WATSON LABS

APPLICATION
ANDA084279
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-23
LATEST ACTION
2002-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COL-PROBENECID · ReferencePrescription
COLCHICINE 0.5MG, PROBENECID 500MG · TABLET · ORAL

Approval history

2002-05-06Manufacturing (CMC) · Supplement 45AP
2001-04-25Manufacturing (CMC) · Supplement 44AP
1991-05-31Manufacturing (CMC) · Supplement 41AP
1991-01-28Manufacturing (CMC) · Supplement 42AP
1990-06-29Manufacturing (CMC) · Supplement 39AP
1989-11-30Labeling · Supplement 40AP
1988-03-14Manufacturing (CMC) · Supplement 38AP
1988-03-14Manufacturing (CMC) · Supplement 36AP
1988-03-14Manufacturing (CMC) · Supplement 37AP
1985-01-22Manufacturing (CMC) · Supplement 32AP
1984-02-15Manufacturing (CMC) · Supplement 31AP
1983-11-09Manufacturing (CMC) · Supplement 30AP
1983-06-29Manufacturing (CMC) · Supplement 28AP
1983-06-29Manufacturing (CMC) · Supplement 29AP
1983-06-29Manufacturing (CMC) · Supplement 27AP
1982-11-30Manufacturing (CMC) · Supplement 26AP
1982-01-28Manufacturing (CMC) · Supplement 25AP
1976-11-23Original — Review ↗AP
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 →