APPLICATION
ANDA085187
TYPE
ANDA
ORIGINAL APPROVAL
1979-05-15
LATEST ACTION
1999-04-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
SLO-PHYLLINDiscontinued
THEOPHYLLINE 80MG/15ML · SYRUP · ORAL
Approval history
1999-04-29Manufacturing (CMC) · Supplement 28AP
1993-04-05Manufacturing (CMC) · Supplement 26AP
1993-03-04Labeling · Supplement 23AP
1993-03-04Manufacturing (CMC) · Supplement 24AP
1993-03-04Manufacturing (CMC) · Supplement 22AP
1990-06-13Labeling · Supplement 21AP
1988-09-01Manufacturing (CMC) · Supplement 20AP
1984-05-01Manufacturing (CMC) · Supplement 17AP
1983-04-11Manufacturing (CMC) · Supplement 15AP
1983-02-08Manufacturing (CMC) · Supplement 14AP
1982-07-08Manufacturing (CMC) · Supplement 9AP
1982-07-08Manufacturing (CMC) · Supplement 12AP
1982-07-08Manufacturing (CMC) · Supplement 8AP
1982-07-08Manufacturing (CMC) · Supplement 10AP
1979-05-15OriginalAP
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.