← FDA DRUG APPROVALS

FDA ANDA · ANDA089823

UNI-DUR

Sponsor: SCHERING

APPLICATION
ANDA089823
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-04
LATEST ACTION
2002-01-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

UNI-DURDiscontinued
THEOPHYLLINE 600MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-01-10Labeling · Supplement 8 — Review ↗AP
1997-06-18Labeling · Supplement 5 — Review ↗AP
1997-06-18Labeling · Supplement 4 — Review ↗AP
1995-05-12Manufacturing (CMC) · Supplement 2 — Review ↗AP
1995-01-31Labeling · Supplement 1 — Review ↗AP
1995-01-04OriginalAP
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 →