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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Express Scripts

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078309

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NDA 078309 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 twelve 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. Sixteen suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.
Summary for 078309
Applicant:Mylan Speciality Lp
Ingredient:levalbuterol hydrochloride
Therapeutic Class:Respiratory Tract Agents
Pharmacology for NDA: 078309
Mechanism of ActionAdrenergic beta2-Agonists
Suppliers and Packaging for NDA: 078309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078309 ANDA Mylan Pharmaceuticals Inc. 0378-6993 N 0378-6993-93
LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078309 ANDA Cardinal Health 55154-6260 E 55154-6260-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrengthEQ 0.25% BASE
Approval Date:Mar 20, 2009TE:ANRLD:No

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