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LYSODREN

NDA · New Drug Application · Sponsor: ESTEVE · Approved 1970-07-08

Drug application

FDA Application #

NDA016885

Application type

New Drug Application

Brand name

LYSODREN

Generic name

MITOTANE

Active ingredients

MITOTANE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ESTEVE

Manufacturer

ESTEVE PHARMACEUTICALS, S.A.

First approval

1970-07-08

Source

Authoritative

Drugs@FDA application overview

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