← FDA Drug Approvals (Drugs@FDA)

URSODIOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 2020-08-17

Drug application

FDA Application #

ANDA213555

Application type

Abbreviated New Drug Application (Generic)

Brand name

URSODIOL

Generic name

URSODIOL

Active ingredients

URSODIOL

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

CHARTWELL RX

Manufacturer

Chartwell RX, LLC

First approval

2020-08-17

Source

Authoritative

Drugs@FDA application overview

Machine

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