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AMNESTEEM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMS INC · Approved 2002-11-08

Drug application

FDA Application #

ANDA075945

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMNESTEEM

Generic name

ISOTRETINOIN

Active ingredients

ISOTRETINOIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

MYLAN PHARMS INC

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2002-11-08

Source

Authoritative

Drugs@FDA application overview

Machine

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