APPLICATION
ANDA088689
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-12
LATEST ACTION
1992-09-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 250MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1992-09-01Labeling · Supplement 2AP
1985-02-12OriginalAP
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.