← FDA DRUG APPROVALS

FDA ANDA · ANDA089822

UNI-DUR

Sponsor: SCHERING

APPLICATION
ANDA089822
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 400MG · 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.

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