APPLICATION
ANDA085263
TYPE
ANDA
ORIGINAL APPROVAL
1979-07-13
LATEST ACTION
1997-03-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
THEOPHYLLINEDiscontinued
THEOPHYLLINE 200MG · CAPSULE · ORAL
THEOPHYLLINEDiscontinued
THEOPHYLLINE 100MG · CAPSULE · ORAL
Approval history
1997-03-03Labeling · Supplement 25AP
1995-03-01Labeling · Supplement 24AP
1991-05-24Labeling · Supplement 17AP
1991-02-05Labeling · Supplement 14AP
1979-07-13OriginalAP
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.