Details for New Drug Application (NDA): 020692

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NDA 020692 describes SEREVENT, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from one supplier. Additional details are available on the SEREVENT profile page.

The generic ingredient in SEREVENT is salmeterol xinafoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the salmeterol xinafoate profile page.

Summary for 020692

Tradename:	SEREVENT
Applicant:	Glaxosmithkline
Ingredient:	salmeterol xinafoate
Patents:	0

Pharmacology for NDA: 020692

Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 020692

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents

Suppliers and Packaging for NDA: 020692

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692	NDA	GlaxoSmithKline LLC	0173-0521	0173-0521-00	1 INHALER in 1 CARTON (0173-0521-00) / 60 POWDER, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	EQ 0.05MG BASE/INH
Approval Date:	Sep 19, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020692

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,860,419*PED	⤷ Subscribe
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	4,992,474*PED	⤷ Subscribe
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	6,536,427*PED	⤷ Subscribe
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	6,378,519*PED	⤷ Subscribe
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