← FDA DRUG APPROVALS

FDA ANDA · ANDA073475

ATENOLOL

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA073475
TYPE
ANDA
ORIGINAL APPROVAL
1993-03-30
LATEST ACTION
2015-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ATENOLOLDiscontinued
ATENOLOL 50MG · TABLET · ORAL

Approval history

2015-04-29Labeling · Supplement 37 · standardAP
2011-10-24Labeling · Supplement 36AP
2010-03-15Labeling · Supplement 35AP
2005-08-26Labeling · Supplement 25AP
2005-05-03Labeling · Supplement 24AP
2002-07-24Manufacturing (CMC) · Supplement 15AP
2002-02-19Manufacturing (CMC) · Supplement 14AP
2000-09-05Labeling · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
1997-12-05Manufacturing (CMC) · Supplement 8AP
1997-02-24Manufacturing (CMC) · Supplement 7AP
1996-11-25Labeling · Supplement 6AP
1995-06-22Manufacturing (CMC) · Supplement 5AP
1994-10-13Labeling · Supplement 4AP
1994-01-12Manufacturing (CMC) · Supplement 2AP
1993-12-16Labeling · Supplement 3AP
1993-04-19Labeling · Supplement 1AP
1993-03-30OriginalAP
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 →