APPLICATION
ANDA211655
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-28
LATEST ACTION
2022-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 15MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG · TABLET, EXTENDED RELEASE · ORAL
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 10MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-08-25Labeling · Supplement 16 · standardAP
2020-02-28Labeling · Supplement 1 · standardAP
2019-02-28UNKNOWN · Original · standardAP
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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