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Details for New Drug Application (NDA): 020983

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NDA 020983 describes VENTOLIN HFA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from eleven suppliers. There are sixteen patents protecting this drug. Additional details are available on the VENTOLIN HFA profile page.

The generic ingredient in VENTOLIN HFA is albuterol sulfate. There are thirty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

Summary for NDA: 020983

Tradename:
VENTOLIN HFA
Applicant:
Glaxosmithkline
Ingredient:
albuterol sulfate
Patents:16
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020983

Mechanism of ActionAdrenergic beta2-Agonists

Suppliers and Packaging for NDA: 020983

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION 020983 NDA GlaxoSmithKline LLC 0173-0682 0173-0682-20 1 INHALER in 1 CARTON (0173-0682-20) > 200 AEROSOL, METERED in 1 INHALER
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION 020983 NDA GlaxoSmithKline LLC 0173-0682 0173-0682-21 1 INHALER in 1 CARTON (0173-0682-21) > 60 AEROSOL, METERED in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Apr 19, 2001TE:BXRLD:Yes
Patent:6,161,724*PEDPatent Expiration:Jul 16, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,170,717*PEDPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,315,173*PEDPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020983

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,131,566*PED► subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,596,260*PED► subscribe
Glaxosmithkline
VENTOLIN HFA
albuterol sulfate
AEROSOL, METERED;INHALATION020983-001Apr 19, 20016,532,955*PED► subscribe
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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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