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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021077

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NDA 021077 describes ADVAIR DISKUS 500/50, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from nine suppliers. There is one patent protecting this drug. Additional details are available on the ADVAIR DISKUS 500/50 profile page.

The generic ingredient in ADVAIR DISKUS 500/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 021077
Tradename:ADVAIR DISKUS 500/50
Applicant:Glaxo Grp Ltd
Ingredient:fluticasone propionate; salmeterol xinafoate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021077
Suppliers and Packaging for NDA: 021077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077 NDA GlaxoSmithKline LLC 0173-0695 0173-0695-00 1 INHALER in 1 CARTON (0173-0695-00) > 60 POWDER in 1 INHALER
ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077 NDA GlaxoSmithKline LLC 0173-0695 0173-0695-61 1 INHALER in 1 CARTON (0173-0695-61) > 14 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date:Aug 24, 2000TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021077

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd ADVAIR DISKUS 500/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-003 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 500/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-003 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-001 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 500/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-003 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Glaxo Grp Ltd ADVAIR DISKUS 250/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077-002 Aug 24, 2000 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Citi
Harvard Business School
Federal Trade Commission
Deloitte
Fuji
Boehringer Ingelheim
US Department of Justice
Merck
McKinsey

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