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AZELASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2020-02-25

Drug application

FDA Application #

ANDA210092

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

GLAND

Manufacturer

Gland Pharma Limited

First approval

2020-02-25

Source

Authoritative

Drugs@FDA application overview

Machine

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