← FDA DRUG APPROVALS

FDA ANDA · ANDA083740

PROBENECID

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA083740
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-09
LATEST ACTION
2002-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROBENECIDDiscontinued
PROBENECID 500MG · TABLET · ORAL

Approval history

2002-11-15Manufacturing (CMC) · Supplement 16AP
2002-07-29Manufacturing (CMC) · Supplement 17AP
2001-01-02Manufacturing (CMC) · Supplement 14AP
2001-01-02Manufacturing (CMC) · Supplement 12AP
2001-01-02Manufacturing (CMC) · Supplement 15AP
2001-01-02Manufacturing (CMC) · Supplement 13AP
2000-03-28Manufacturing (CMC) · Supplement 11AP
2000-01-28Manufacturing (CMC) · Supplement 10AP
1999-11-23Manufacturing (CMC) · Supplement 9AP
1999-08-20Manufacturing (CMC) · Supplement 8AP
1998-12-09Manufacturing (CMC) · Supplement 7AP
1997-05-30Manufacturing (CMC) · Supplement 6AP
1996-01-31Manufacturing (CMC) · Supplement 5AP
1992-09-28Manufacturing (CMC) · Supplement 3AP
1992-09-28Manufacturing (CMC) · Supplement 4AP
1988-03-23Manufacturing (CMC) · Supplement 1AP
1988-03-11Manufacturing (CMC) · Supplement 2AP
1984-05-09OriginalAP
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 →