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Generated: April 26, 2017

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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 Sandoz Inc, Upsher-smith Labs, Apotex Inc, Sun Pharma Global, Perrigo Israel, West-ward Pharms Int, Akorn, and Breckenridge Pharm, and is included in eleven NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for NDA: 077954

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
SPRAY, METERED;NASAL 077954 ANDA A-S Medication Solutions 50090-2330 50090-2330-0 1 BOTTLE, SPRAY in 1 CARTON (50090-2330-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
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

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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