← FDA Drug Approvals (Drugs@FDA)

AZELASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2017-12-15

Drug application

FDA Application #

ANDA208199

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

Discontinued

Sponsor

AMNEAL

First approval

2017-12-15

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown