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FDA ANDA · ANDA206121
OXYBUTYNIN CHLORIDE EXTENDED RELEASE
oxybutynin chloride
Sponsor: UNIQUE
APPLICATION
ANDA206121
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-27
LATEST ACTION
2023-05-24
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
2023-05-24Labeling · Supplement 6 · standardAP
2020-02-28Labeling · Supplement 5 · standardAP
2019-08-19Labeling · Supplement 2 · standardAP
2019-08-19Labeling · Supplement 3 · standardAP
2016-05-27UNKNOWN · 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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