APPLICATION
ANDA074520
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-29
LATEST ACTION
2011-11-02
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG/5ML · SYRUP · ORAL
Approval history
2011-11-02Labeling · Supplement 5AP
2010-09-20Labeling · Supplement 4AP
2001-07-11Manufacturing (CMC) · Supplement 3AP
1999-03-04Manufacturing (CMC) · Supplement 2AP
1999-03-04Manufacturing (CMC) · Supplement 1AP
1996-03-29OriginalAP
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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