← FDA DRUG APPROVALS

FDA ANDA · ANDA085204

SLO-PHYLLIN

Sponsor: SANOFI AVENTIS US

APPLICATION
ANDA085204
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-14
LATEST ACTION
1999-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SLO-PHYLLINDiscontinued
THEOPHYLLINE 200MG · TABLET · ORAL

Approval history

1999-04-29Manufacturing (CMC) · Supplement 23AP
1990-11-27Labeling · Supplement 20AP
1990-07-26Labeling · Supplement 19AP
1990-06-18Manufacturing (CMC) · Supplement 18AP
1988-10-05Labeling · Supplement 16AP
1985-11-01Manufacturing (CMC) · Supplement 14AP
1985-07-26Manufacturing (CMC) · Supplement 8AP
1984-07-30Manufacturing (CMC) · Supplement 12AP
1984-01-10Manufacturing (CMC) · Supplement 10AP
1984-01-10Manufacturing (CMC) · Supplement 11AP
1983-02-14Manufacturing (CMC) · Supplement 7AP
1982-07-15Manufacturing (CMC) · Supplement 5AP
1982-07-15Manufacturing (CMC) · Supplement 6AP
1979-11-14OriginalAP
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 →