APPLICATION
ANDA076745
TYPE
ANDA
ORIGINAL APPROVAL
2006-11-09
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-06-12Labeling · Supplement 21 · standardAP
2024-06-12Labeling · Supplement 24 · standardAP
2015-09-02Labeling · Supplement 18 · standardAP
2015-09-02Labeling · Supplement 14 · standardAP
2013-08-29Labeling · Supplement 10 · standardAP
2010-07-19Labeling · Supplement 5AP
2007-05-09Manufacturing (CMC) · Supplement 2AP
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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