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Details for New Drug Application (NDA): 021254

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NDA 021254 describes ADVAIR HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the ADVAIR HFA profile page.

The generic ingredient in ADVAIR HFA 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: 021254

Tradename:
ADVAIR HFA
Applicant:
Glaxo Grp Ltd
Ingredient:
fluticasone propionate; salmeterol xinafoate
Patents:15
Formulation / Manufacturing:see details

Pharmacology for NDA: 021254

Suppliers and Packaging for NDA: 021254

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION 021254 NDA GlaxoSmithKline LLC 0173-0715 0173-0715-20 1 INHALER in 1 CARTON (0173-0715-20) > 120 AEROSOL, METERED in 1 INHALER
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION 021254 NDA GlaxoSmithKline LLC 0173-0715 0173-0715-22 1 INHALER in 1 CARTON (0173-0715-22) > 60 AEROSOL, METERED in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.045MG/INH;EQ 0.021MG BASE/INH
Approval Date:Jun 8, 2006TE:RLD:Yes
Patent:6,161,724*PEDPatent Expiration:Jul 16, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,170,717*PEDPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:6,315,173*PEDPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021254

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-002Jun 8, 20064,992,474*PED► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-003Jun 8, 20066,143,277► subscribe
Glaxo Grp Ltd
ADVAIR HFA
fluticasone propionate; salmeterol xinafoate
AEROSOL, METERED;INHALATION021254-001Jun 8, 20066,546,928*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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