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AZELASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2019-03-29

Drug application

FDA Application #

ANDA207411

Application type

Abbreviated New Drug Application (Generic)

Brand name

AZELASTINE HYDROCHLORIDE

Generic name

AZELASTINE HYDROCHLORIDE

Active ingredients

AZELASTINE HYDROCHLORIDE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2019-03-29

Source

Authoritative

Drugs@FDA application overview

Machine

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