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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Fish and Richardson
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Citi
Healthtrust
Johnson and Johnson
Accenture
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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202305

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NDA 202305 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Sandoz Inc, Upsher-smith Labs, Zydus Pharms Usa Inc, Apotex Inc, Sun Pharma Global, Perrigo Israel, West-ward Pharms Int, Alkem Labs Ltd, Akorn, Amneal Pharms Llc, and Breckenridge Pharm, and is included in sixteen NDAs. It is available from thirteen 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. Two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.

Summary for NDA: 202305

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Ophthalmic Agents
Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 202305

Suppliers and Packaging for NDA: 202305

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 202305 ANDA Sandoz Inc 61314-308 61314-308-02 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) > 6 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:May 31, 2012TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Argus Health
Deloitte
US Army
Harvard Business School
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Healthtrust
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McKesson
Chinese Patent Office

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