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DARIFENACIN HYDROBROMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2017-12-08

Drug application

FDA Application #

ANDA207681

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

ALEMBIC

Manufacturer

Alembic Pharmaceuticals Limited

First approval

2017-12-08

Source

Authoritative

Drugs@FDA application overview

Machine

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