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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-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

Summary for NDA: 021077

Tradename:
ADVAIR DISKUS 100/50
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 0173-0695-04 1 INHALER in 1 CARTON (0173-0695-04) > 14 POWDER in 1 INHALER

Summary 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:5,873,360*PEDPatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?Y

Summary 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:5,873,360*PEDPatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?Y

Summary 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:5,873,360*PEDPatent Expiration:Aug 23, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021077

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR DISKUS 250/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-002Aug 24, 20007,389,775*PED► subscribe
Glaxo Grp Ltd
ADVAIR DISKUS 500/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-003Aug 24, 20006,378,519*PED► subscribe
Glaxo Grp Ltd
ADVAIR DISKUS 500/50
fluticasone propionate; salmeterol xinafoate
POWDER;INHALATION021077-003Aug 24, 20005,290,815*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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