APPLICATION
ANDA076682
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-28
LATEST ACTION
2008-10-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
OXYBUTYNIN CHLORIDEDiscontinued
OXYBUTYNIN CHLORIDE 5MG/5ML · SYRUP · ORAL
Approval history
2008-10-29Labeling · Supplement 2AP
2007-02-01Labeling · Supplement 1AP
2004-12-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.