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AZELASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2009-04-30

Drug application

FDA Application #

ANDA077954

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

APOTEX INC

Manufacturer

Apotex Corp.

First approval

2009-04-30

Source

Authoritative

Drugs@FDA application overview

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