APPLICATION
ANDA078503
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-04
LATEST ACTION
2019-09-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-09-09Labeling · Supplement 9 · standardAP
2019-09-09Labeling · Supplement 7 · standardAP
2015-11-04Labeling · Supplement 5 · standardAP
2015-11-04Labeling · Supplement 6 · standardAP
2013-08-30Labeling · Supplement 3 · standardAP
2013-08-30Labeling · Supplement 4 · standardAP
2010-04-07Labeling · 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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