Details for New Drug Application (NDA): 020503

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NDA 020503 describes PROVENTIL-HFA, which is a drug marketed by Kindeva and is included in one NDA. It is available from nine suppliers. Additional details are available on the PROVENTIL-HFA profile page.

The generic ingredient in PROVENTIL-HFA is albuterol sulfate. There are thirty-eight 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 020503

Tradename:	PROVENTIL-HFA
Applicant:	Kindeva
Ingredient:	albuterol sulfate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020503

Mechanism of Action	Adrenergic beta2-Agonists

Suppliers and Packaging for NDA: 020503

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA	Merck Sharp & Dohme Corp.	0085-1132	0085-1132-04	1 CANISTER in 1 CARTON (0085-1132-04) > 200 AEROSOL, METERED in 1 CANISTER
PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503	NDA AUTHORIZED GENERIC	Par Pharmaceutical Inc.	0254-1007	0254-1007-52	1 CANISTER in 1 CARTON (0254-1007-52) > 200 AEROSOL, METERED in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	EQ 0.09MG BASE/INH
Approval Date:	Aug 15, 1996	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 020503

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	See Plans and Pricing	See Plans and Pricing
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	See Plans and Pricing	See Plans and Pricing
Kindeva	PROVENTIL-HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020503-001	Aug 15, 1996	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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