APPLICATION
ANDA087863
TYPE
ANDA
ORIGINAL APPROVAL
1983-05-24
LATEST ACTION
1999-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CHOLEDYL SADiscontinued
OXTRIPHYLLINE 400MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1999-06-08Manufacturing (CMC) · Supplement 18AP
1999-06-08Labeling · Supplement 20AP
1999-06-08Manufacturing (CMC) · Supplement 19AP
1998-02-24Manufacturing (CMC) · Supplement 16AP
1998-02-24Manufacturing (CMC) · Supplement 15AP
1993-07-19Labeling · Supplement 12AP
1992-08-12Manufacturing (CMC) · Supplement 11AP
1991-11-05Labeling · Supplement 1AP
1991-08-21Manufacturing (CMC) · Supplement 9AP
1991-08-21Manufacturing (CMC) · Supplement 7AP
1991-08-21Manufacturing (CMC) · Supplement 8AP
1984-04-17Manufacturing (CMC) · Supplement 2AP
1984-04-17Manufacturing (CMC) · Supplement 3AP
1983-05-24OriginalAP
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.
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