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ISOTRETINOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL · Approved 2021-03-31

Drug application

FDA Application #

ANDA205063

Application type

Abbreviated New Drug Application (Generic)

Brand name

ISOTRETINOIN

Generic name

ISOTRETINOIN

Active ingredients

ISOTRETINOIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS FL

Manufacturer

Actavis Pharma, Inc.

First approval

2021-03-31

Source

Authoritative

Drugs@FDA application overview

Machine

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