APPLICATION
ANDA075039
TYPE
ANDA
ORIGINAL APPROVAL
1999-01-29
LATEST ACTION
2006-10-26
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG/5ML · SYRUP · ORAL
Approval history
2006-10-26Labeling · Supplement 4AP
2002-08-13Manufacturing (CMC) · Supplement 1AP
1999-01-29OriginalAP
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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