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FDA Drug information

AZELASTINE HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 29 Apr 2024

Summary of product characteristics


Effective Time

20221013

Version

5

Spl Product Data Elements

AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE AZELASTINE SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE HYPROMELLOSES EDETATE DISODIUM CITRIC ACID MONOHYDRATE BENZALKONIUM CHLORIDE WATER

Application Number

ANDA091409

Brand Name

AZELASTINE HYDROCHLORIDE

Generic Name

AZELASTINE HYDROCHLORIDE

Product Ndc

70771-1313

Product Type

HUMAN PRESCRIPTION DRUG

Route

NASAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1313-2 Azelastine Hydrochloride Nasal Spray, 137 mcg per spray 30 mL Rx only Azelastine hydrochloride nasal spray

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