APPLICATION
ANDA071655
TYPE
ANDA
ORIGINAL APPROVAL
1988-11-14
LATEST ACTION
2012-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG · TABLET · ORAL
Approval history
2012-06-13Labeling · Supplement 25 · standardAP
2011-10-28Labeling · Supplement 24AP
2010-03-09Labeling · Supplement 23AP
2008-02-19Labeling · Supplement 15AP
2001-05-29Manufacturing (CMC) · Supplement 12AP
2001-05-24Manufacturing (CMC) · Supplement 9AP
2001-05-24Manufacturing (CMC) · Supplement 10AP
2001-05-24Manufacturing (CMC) · Supplement 8AP
2001-03-20Manufacturing (CMC) · Supplement 11AP
2000-07-07Manufacturing (CMC) · Supplement 7AP
1996-10-31Manufacturing (CMC) · Supplement 6AP
1994-05-11Manufacturing (CMC) · Supplement 5AP
1994-02-15Manufacturing (CMC) · Supplement 1AP
1992-06-04Labeling · Supplement 4AP
1992-02-27Labeling · Supplement 3AP
1990-02-21Labeling · Supplement 2AP
1988-11-14OriginalAP
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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