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DARIFENACIN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PURACAP LABS BLU · Approved 2020-01-06

Drug application

FDA Application #
ANDA211045
Application type
Abbreviated New Drug Application (Generic)
Brand name
DARIFENACIN HYDROBROMIDE
Generic name
DARIFENACIN HYDROBROMIDE
Active ingredients
DARIFENACIN HYDROBROMIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
PURACAP LABS BLU
Manufacturer
POLYGEN PHARMACEUTICALS INC.
First approval
2020-01-06

Source

Authoritative
Drugs@FDA application overview
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