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Last Updated: February 25, 2021

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Details for New Drug Application (NDA): 090176

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NDA 090176 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Akorn, Alembic Pharms Ltd, Apotex Inc, Gland Pharma Ltd, Sandoz Inc, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Breckenridge, Hikma, Perrigo Israel, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-four NDAs. It is available from eighteen suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 090176
Tradename:AZELASTINE HYDROCHLORIDE
Applicant:Breckenridge
Ingredient:azelastine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090176
Suppliers and Packaging for NDA: 090176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE azelastine hydrochloride SPRAY, METERED;NASAL 090176 ANDA Breckenridge Pharmaceutical, Inc. 51991-814 51991-814-03 1 BOTTLE, SPRAY in 1 CARTON (51991-814-03) > 30 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Jul 28, 2015TE:ABRLD:No

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