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Details for New Drug Application (NDA): 020549

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NDA 020549 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-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

Summary for NDA: 020549

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength0.044MG/INH
Approval Date:Nov 7, 1997TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength0.088MG/INH
Approval Date:Nov 7, 1997TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;INHALATIONStrength0.22MG/INH
Approval Date:Nov 7, 1997TE:RLD:No

Expired Orange Book Patents for NDA: 020549

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
fluticasone propionate
POWDER;INHALATION020549-001Nov 7, 19974,335,121*PED► subscribe
fluticasone propionate
POWDER;INHALATION020549-003Nov 7, 19974,335,121*PED► subscribe
fluticasone propionate
POWDER;INHALATION020549-002Nov 7, 19974,335,121*PED► subscribe
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