APPLICATION
ANDA085186
TYPE
ANDA
ORIGINAL APPROVAL
1979-01-26
LATEST ACTION
2014-06-26
ROUTE
ORAL
DOSAGE FORM
SOLUTION, ELIXIR
MARKETING STATUS
Discontinued
Products
ELIXOPHYLLIN · ReferenceDiscontinued
THEOPHYLLINE 80MG/15ML · SOLUTION, ELIXIR · ORAL
Approval history
2014-06-26Labeling · Supplement 25 · standardAP
1999-02-18Labeling · Supplement 18AP
1993-02-22Manufacturing (CMC) · Supplement 17AP
1989-02-17Labeling · Supplement 13AP
1987-02-06Manufacturing (CMC) · Supplement 10AP
1987-02-06Manufacturing (CMC) · Supplement 11AP
1982-05-24Manufacturing (CMC) · Supplement 7AP
1982-03-05Manufacturing (CMC) · Supplement 6AP
1979-01-26OriginalAP
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.