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Details for New Drug Application (NDA): 020548

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NDA 020548 describes FLOVENT, which is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in four NDAs. There are sixteen patents protecting this drug. Additional details are available on the FLOVENT profile page.

The generic ingredient in FLOVENT is fluticasone propionate. There are twenty-two drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 020548

fluticasone propionate
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL, METERED;INHALATIONStrength0.044MG/INH
Approval Date:Mar 27, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL, METERED;INHALATIONStrength0.11MG/INH
Approval Date:Mar 27, 1996TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL, METERED;INHALATIONStrength0.22MG/INH
Approval Date:Mar 27, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020548

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
fluticasone propionate
AEROSOL, METERED;INHALATION020548-001Mar 27, 19964,335,121*PED► subscribe
fluticasone propionate
AEROSOL, METERED;INHALATION020548-002Mar 27, 19964,335,121*PED► subscribe
fluticasone propionate
AEROSOL, METERED;INHALATION020548-003Mar 27, 19964,335,121*PED► subscribe
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