← FDA DRUG APPROVALS

FDA ANDA · ANDA078254

ATENOLOL

Sponsor: NORTHSTAR HLTHCARE

APPLICATION
ANDA078254
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-25
LATEST ACTION
2014-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ATENOLOLDiscontinued
ATENOLOL 50MG · TABLET · ORAL
ATENOLOLDiscontinued
ATENOLOL 100MG · TABLET · ORAL
ATENOLOLDiscontinued
ATENOLOL 25MG · TABLET · ORAL

Approval history

2014-12-11Labeling · Supplement 3 · standardAP
2014-12-11Labeling · Supplement 4 · standardAP
2014-12-11Labeling · Supplement 2AP
2009-09-25OriginalAP
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 →