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Generated: December 15, 2017

DrugPatentWatch Database Preview

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 two suppliers. There is one patent protecting this drug. Additional details are available on the SEREVENT profile page.

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

Summary for 020692

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020692

Mechanism of ActionAdrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for 020692

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 0173-0520 0173-0520-00 1 INHALER in 1 CARTON (0173-0520-00) > 28 POWDER, METERED in 1 INHALER
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.05MG BASE/INH
Approval Date:Sep 19, 1997TE:RLD:Yes
Patent:► SubscribePatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020692

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
GlaxosmithklineSEREVENTsalmeterol xinafoatePOWDER;INHALATION020692-001Sep 19, 1997► Subscribe► Subscribe
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