APPLICATION
ANDA087462
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-16
LATEST ACTION
1994-09-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 260MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
1994-09-16OriginalAP
1985-10-09Manufacturing (CMC) · Supplement 7AP
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.