APPLICATION
ANDA074625
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-31
LATEST ACTION
2013-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG · TABLET · ORAL
Approval history
2013-07-31Labeling · Supplement 23 · standardAP
2012-04-26Labeling · Supplement 21AP
2012-04-26Labeling · Supplement 22AP
2010-03-03Labeling · Supplement 17AP
2009-01-06Labeling · Supplement 14AP
2006-12-17Labeling · Supplement 10AP
1999-01-08Manufacturing (CMC) · Supplement 3AP
1996-10-30Manufacturing (CMC) · Supplement 2AP
1996-09-03Labeling · Supplement 1AP
1996-07-31OriginalAP
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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