APPLICATION
ANDA084514
TYPE
ANDA
ORIGINAL APPROVAL
1976-08-16
LATEST ACTION
1996-02-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DILORDiscontinued
DYPHYLLINE 200MG · TABLET · ORAL
Approval history
1996-02-22Manufacturing (CMC) · Supplement 27AP
1993-03-04Manufacturing (CMC) · Supplement 26AP
1992-02-10Manufacturing (CMC) · Supplement 24AP
1992-02-10Manufacturing (CMC) · Supplement 25AP
1992-02-10Manufacturing (CMC) · Supplement 23AP
1988-11-25Manufacturing (CMC) · Supplement 21AP
1988-11-25Manufacturing (CMC) · Supplement 22AP
1983-01-13Manufacturing (CMC) · Supplement 18AP
1983-01-13Manufacturing (CMC) · Supplement 19AP
1981-11-03Manufacturing (CMC) · Supplement 3AP
1976-08-16OriginalAP
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.