APPLICATION
ANDA084731
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-07
LATEST ACTION
1990-12-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 250MG · CAPSULE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 200MG · CAPSULE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 100MG · CAPSULE · ORAL
Approval history
1990-12-26Labeling · Supplement 1AP
1986-10-07OriginalAP
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.