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Details for New Drug Application (NDA): 077954

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NDA 077954 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alcon Pharma, Apotex Inc, Sun Pharma Global, Perrigo Israel, Roxane, Akorn, and Breckenridge Pharms, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.

The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for NDA: 077954

Tradename:
AZELASTINE HYDROCHLORIDE
Applicant:
Apotex Inc
Ingredient:
azelastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077954

Suppliers and Packaging for NDA: 077954

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SPRAY, METERED;NASAL 077954 ANDA Physicians Total Care, Inc. 54868-6131 54868-6131-0 1 BOTTLE, SPRAY in 1 CARTON (54868-6131-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SPRAY, METERED;NASAL 077954 ANDA Apotex Corp. 60505-0833 60505-0833-5 1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Apr 30, 2009TE:ABRLD:No


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