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Serving hundreds of leading biopharmaceutical companies globally:

Dow
QuintilesIMS
Express Scripts
Healthtrust
US Department of Justice
Boehringer Ingelheim
US Army
Merck
Baxter

Generated: June 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 eight suppliers. 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. Ten 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:0
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 N 0173-0695-00
ADVAIR DISKUS 100/50 fluticasone propionate; salmeterol xinafoate POWDER;INHALATION 021077 NDA GlaxoSmithKline LLC 0173-0695 N 0173-0695-04

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
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS

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
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS

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
Regulatory Exclusivity Expiration:Dec 20, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS

Expired US Patents for NDA 021077

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Julphar
Medtronic
Federal Trade Commission
Farmers Insurance
Citi
Moodys
Merck

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