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Generated: November 14, 2018

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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 fourteen suppliers. There are fifteen 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-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
Summary for 020983
Tradename:VENTOLIN HFA
Applicant:Glaxosmithkline
Ingredient:albuterol sulfate
Patents:15
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrengthEQ 0.09MG BASE/INH
Approval Date:Apr 19, 2001TE:BXRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 16, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020983

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ➤ Sign Up ➤ Sign Up
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ➤ Sign Up ➤ Sign Up
Glaxosmithkline VENTOLIN HFA albuterol sulfate AEROSOL, METERED;INHALATION 020983-001 Apr 19, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fuji
McKinsey
Express Scripts
AstraZeneca
Federal Trade Commission
Healthtrust
Dow
Cerilliant

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