Details for New Drug Application (NDA): 020114

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NDA 020114 describes ASTELIN, which is a drug marketed by Norvium Bioscience and is included in one NDA. Additional details are available on the ASTELIN profile page.

The generic ingredient in ASTELIN is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 020114

Tradename:	ASTELIN
Applicant:	Norvium Bioscience
Ingredient:	azelastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 1, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020114

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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