APPLICATION
ANDA207664
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-01
LATEST ACTION
2022-02-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
DARIFENACIN HYDROBROMIDEPrescription
DARIFENACIN HYDROBROMIDE EQ 7.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
DARIFENACIN HYDROBROMIDEPrescription
DARIFENACIN HYDROBROMIDE EQ 15MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-02-18Labeling · Supplement 4 · standardAP
2016-09-01UNKNOWN · 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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