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Last Updated: December 9, 2019

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Details for New Drug Application (NDA): 021433

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NDA 021433 describes FLOVENT HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from five suppliers. There are five patents protecting this drug. Additional details are available on the FLOVENT HFA profile page.

The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Eighty-one suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 021433
Tradename:FLOVENT HFA
Applicant:Glaxo Grp Ltd
Ingredient:fluticasone propionate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 021433
Suppliers and Packaging for NDA: 021433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433 NDA GlaxoSmithKline LLC 0173-0718 0173-0718-20 1 INHALER in 1 CARTON (0173-0718-20) > 120 AEROSOL, METERED in 1 INHALER
FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433 NDA GlaxoSmithKline LLC 0173-0719 0173-0719-20 1 INHALER in 1 CARTON (0173-0719-20) > 120 AEROSOL, METERED in 1 INHALER
Paragraph IV (Patent) Challenges for 021433
Tradename Dosage Ingredient NDA Submissiondate
FLOVENT HFA AEROSOL, METERED;INHALATION fluticasone propionate 021433 2016-12-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.22MG/INH
Approval Date:May 14, 2004TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 24, 2019Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 26, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Dec 19, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021433

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004   Start Trial   Start Trial
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-003 May 14, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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