APPLICATION
ANDA088364
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-16
LATEST ACTION
1999-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOLAIR-SRDiscontinued
THEOPHYLLINE 300MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-12-03Manufacturing (CMC) · Supplement 12AP
1999-07-06Manufacturing (CMC) · Supplement 11AP
1998-10-08Manufacturing (CMC) · Supplement 10AP
1998-05-29Labeling · Supplement 8AP
1998-01-13Manufacturing (CMC) · Supplement 9AP
1991-02-15Labeling · Supplement 6AP
1991-01-15Manufacturing (CMC) · Supplement 5AP
1991-01-15Manufacturing (CMC) · Supplement 4AP
1989-04-28Manufacturing (CMC) · Supplement 1AP
1989-04-28Manufacturing (CMC) · Supplement 2AP
1987-07-16OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.