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 ten suppliers. 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-three 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:	0

Pharmacology for NDA: 020983

Mechanism of Action	Adrenergic 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	0173-0682-24	1 INHALER in 1 CARTON (0173-0682-24) / 60 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	Apr 19, 2001	TE:	BX	RLD:	Yes

Expired US 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;INHALATION	020983-001	Apr 19, 2001	6,558,651*PED	⤷ Subscribe
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	7,143,908*PED	⤷ Subscribe
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,966,467*PED	⤷ Subscribe
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,315,173*PED	⤷ Subscribe
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