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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Merck
Covington
QuintilesIMS
US Army
Harvard Business School
Novartis
Medtronic

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078171

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NDA 078171 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 078171
Tradename:LEVALBUTEROL HYDROCHLORIDE
Applicant:Cipla Ltd
Ingredient:levalbuterol hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 078171
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 078171
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171 ANDA Dr. Reddy¿s Laboratories, Inc. 43598-409 43598-409-25 5 POUCH in 1 CARTON (43598-409-25) > 5 VIAL in 1 POUCH (43598-409-05) > 3 mL in 1 VIAL
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078171 ANDA Dr. Reddy¿s Laboratories, Inc. 43598-410 43598-410-25 5 POUCH in 1 CARTON (43598-410-25) > 5 VIAL in 1 POUCH (43598-410-05) > 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.0103% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.021% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.042% BASE
Approval Date:Dec 13, 2013TE:ANRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Colorcon
US Army
Healthtrust
Federal Trade Commission
Cantor Fitzgerald
Merck
Fish and Richardson

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