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DARIFENACIN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2016-09-19

Drug application

FDA Application #

ANDA206743

Application type

Abbreviated New Drug Application (Generic)

Brand name

DARIFENACIN HYDROBROMIDE

Generic name

DARIFENACIN

Active ingredients

DARIFENACIN HYDROBROMIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA

Manufacturer

Rising Pharma Holdings, Inc.

First approval

2016-09-19

Source

Authoritative

Drugs@FDA application overview

Machine

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