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Details for New Drug Application (NDA): 205625
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The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 205625
Tradename: | ARNUITY ELLIPTA |
Applicant: | Glaxosmithkline |
Ingredient: | fluticasone furoate |
Patents: | 8 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 205625
Generic Entry Date for 205625*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH | ||||
Approval Date: | Aug 20, 2014 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 17, 2021 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 205625
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | Start Trial | Start Trial |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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