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Serving leading biopharmaceutical companies globally:

AstraZeneca
Healthtrust
UBS
Covington
Queensland Health
Daiichi Sankyo
Merck
Deloitte
Dow
Federal Trade Commission

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203653

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NDA 203653 describes LEVALBUTEROL HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Impax Labs Inc, Mylan Speciality Lp, Ritedose Corp, Teva Parenteral, and Teva Pharms Usa, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the LEVALBUTEROL HYDROCHLORIDE profile page.

The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.
Summary for 203653
Tradename:LEVALBUTEROL HYDROCHLORIDE
Applicant:Ritedose Corp
Ingredient:levalbuterol hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 203653
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 203653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 203653 ANDA Ritedose Pharmaceuticals, LLC 76204-700 76204-700-55 5 POUCH in 1 CARTON (76204-700-55) > 5 AMPULE in 1 POUCH (76204-700-05) > 3 mL in 1 AMPULE
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 203653 ANDA Ritedose Pharmaceuticals, LLC 76204-700 76204-700-01 30 POUCH in 1 CARTON (76204-700-01) > 1 AMPULE in 1 POUCH (76204-700-11) > 3 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Mar 22, 2016TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Mar 22, 2016TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Mar 22, 2016TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Dow
McKesson
QuintilesIMS
Harvard Business School
Farmers Insurance
Healthtrust
US Army

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