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Generated: November 21, 2017

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 Mylan Speciality Lp, Aurobindo Pharma Ltd, Ritedose Corp, Impax Labs Inc, Cipla Ltd, 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 078309

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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 0378-6993-93 30 POUCH in 1 CARTON (0378-6993-93) > 1 VIAL in 1 POUCH (0378-6993-31) > .5 mL in 1 VIAL
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION 078309 ANDA Cardinal Health 55154-6260 55154-6260-5 5 POUCH in 1 BAG (55154-6260-5) > 1 VIAL in 1 POUCH > .5 mL in 1 VIAL

Summary 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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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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