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AZELASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-05-08

Drug application

FDA Application #

ANDA212289

Application type

Abbreviated New Drug Application (Generic)

Brand name

AZELASTINE HYDROCHLORIDE

Generic name

AZELASTINE HYDROCHLORIDE

Active ingredients

AZELASTINE HYDROCHLORIDE

Dosage form

SPRAY, METERED

Route

NASAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA LTD

Manufacturer

Aurobindo Pharma Limited

First approval

2020-05-08

Source

Authoritative

Drugs@FDA application overview

Machine

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