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Serving 500+ biopharmaceutical companies globally:

Colorcon
McKesson
US Department of Justice
Merck
Fuji
Express Scripts
Accenture
Moodys
AstraZeneca
US Army

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022203

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NDA 022203 describes ASTEPRO, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASTEPRO profile page.

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

Summary for NDA: 022203

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

Pharmacology for NDA: 022203

Suppliers and Packaging for NDA: 022203

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL 022203 NDA Meda Pharmaceuticals Inc. 0037-0243 0037-0243-04 1 BOTTLE, SPRAY in 1 BOX (0037-0243-04) > 22 SPRAY, METERED in 1 BOTTLE, SPRAY
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL 022203 NDA Meda Pharmaceuticals Inc. 0037-0243 0037-0243-30 1 BOTTLE, SPRAY in 1 BOX (0037-0243-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Oct 15, 2008TE:RLD:No
Patent:8,071,073Patent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Aug 30, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 20, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION


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Serving 500+ biopharmaceutical companies globally:

McKinsey
Chubb
Cipla
Moodys
AstraZeneca
Argus Health
Daiichi Sankyo
Colorcon
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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