Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Mallinckrodt
Harvard Business School
McKinsey
Johnson and Johnson

Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020114

See Plans and Pricing

« Back to Dashboard

NDA 020114 describes ASTELIN, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from three suppliers. 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:Mylan Speciality Lp
Ingredient:azelastine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020114
Suppliers and Packaging for NDA: 020114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA Meda Pharmaceuticals 0037-0241 0037-0241-30 1 BOTTLE, SPRAY in 1 BOX (0037-0241-30) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-2538 50090-2538-0 1 BOTTLE, SPRAY in 1 BOX (50090-2538-0) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY
Paragraph IV (Patent) Challenges for 020114
Tradename Dosage Ingredient NDA Submissiondate
ASTELIN SPRAY, METERED;NASAL azelastine hydrochloride 020114 2005-11-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.125MG BASE/SPRAY
Approval Date:Nov 1, 1996TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
AstraZeneca
Moodys
Harvard Business School
Johnson and Johnson

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.