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ABSORICA

NDA · New Drug Application · Sponsor: SUN PHARM INDS INC · Approved 2012-05-25

Drug application

FDA Application #

NDA021951

Application type

New Drug Application

Brand name

ABSORICA

Generic name

ISOTRETINOIN

Active ingredients

ISOTRETINOIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

SUN PHARM INDS INC

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

2012-05-25

Source

Authoritative

Drugs@FDA application overview

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