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AZELAIC ACID

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS UT INC · Approved 2018-11-19

Drug application

FDA Application #

ANDA208011

Application type

Abbreviated New Drug Application (Generic)

Brand name

AZELAIC ACID

Generic name

AZELAIC ACID

Active ingredients

AZELAIC ACID

Dosage form

GEL

Route

TOPICAL

Marketing status

Prescription

Sponsor

ACTAVIS LABS UT INC

Manufacturer

Actavis Pharma, Inc.

First approval

2018-11-19

Source

Authoritative

Drugs@FDA application overview

Machine

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