APPLICATION
ANDA076702
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-09
LATEST ACTION
2019-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-08-19Labeling · Supplement 15 · standardAP
2019-08-19Labeling · Supplement 16 · standardAP
2016-01-22Labeling · Supplement 13 · standardAP
2016-01-22Labeling · Supplement 12 · standardAP
2013-07-26Labeling · Supplement 11 · standardAP
2013-04-29Labeling · Supplement 10 · standardAP
2011-03-01Labeling · Supplement 9AP
2009-03-19Labeling · 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.
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