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URSODIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2018-10-30

Drug application

FDA Application #

ANDA211145

Application type

Abbreviated New Drug Application (Generic)

Brand name

URSODIOL

Generic name

URSODIOL

Active ingredients

URSODIOL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS LIFESCIENCES

Manufacturer

Zydus Pharmaceuticals (USA) Inc.

First approval

2018-10-30

Source

Authoritative

Drugs@FDA application overview

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