APPLICATION
ANDA076644
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-09
LATEST ACTION
2016-01-05
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2016-01-05Labeling · Supplement 16 · standardAP
2016-01-05Labeling · Supplement 14 · standardAP
2013-07-26Labeling · Supplement 13 · standardAP
2013-04-29Labeling · Supplement 12 · standardAP
2011-03-01Labeling · Supplement 11AP
2009-03-20Labeling · Supplement 9AP
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.