← FDA DRUG APPROVALS

FDA ANDA · ANDA083734

PROBENECID AND COLCHICINE

Sponsor: ANI PHARMS

APPLICATION
ANDA083734
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-12
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROBENECID AND COLCHICINEDiscontinued
COLCHICINE 0.5MG, PROBENECID 500MG · TABLET · ORAL

Approval history

2002-07-29Manufacturing (CMC) · Supplement 47AP
2002-03-12Manufacturing (CMC) · Supplement 46AP
2001-07-11Manufacturing (CMC) · Supplement 44AP
2001-07-11Manufacturing (CMC) · Supplement 42AP
2001-07-11Manufacturing (CMC) · Supplement 40AP
2001-07-11Manufacturing (CMC) · Supplement 41AP
2000-01-28Manufacturing (CMC) · Supplement 43AP
1999-08-20Manufacturing (CMC) · Supplement 39AP
1998-12-09Manufacturing (CMC) · Supplement 38AP
1997-05-30Manufacturing (CMC) · Supplement 37AP
1996-02-05Manufacturing (CMC) · Supplement 35AP
1993-08-03Manufacturing (CMC) · Supplement 36AP
1990-01-05Labeling · Supplement 34AP
1988-01-20Manufacturing (CMC) · Supplement 32AP
1988-01-20Manufacturing (CMC) · Supplement 33AP
1988-01-20Manufacturing (CMC) · Supplement 31AP
1987-03-03Manufacturing (CMC) · Supplement 30AP
1987-03-03Manufacturing (CMC) · Supplement 29AP
1978-06-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →