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Generated: January 19, 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 sixteen 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-five 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:16
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 0173-0718 0173-0718-60 1 INHALER in 1 CARTON (0173-0718-60) > 120 AEROSOL, METERED in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.22MG/INH
Approval Date:May 14, 2004TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 16, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jun 23, 2018Product Flag?Substance Flag?Delist Request?

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

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