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ACCUTANE

NDA · New Drug Application · Sponsor: HOFFMANN LA ROCHE · Approved 1982-05-07

Drug application

FDA Application #

NDA018662

Application type

New Drug Application

Brand name

ACCUTANE

Generic name

Isotretinoin

Active ingredients

ISOTRETINOIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Discontinued

Sponsor

HOFFMANN LA ROCHE

First approval

1982-05-07

Source

Authoritative

Drugs@FDA application overview

Machine

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