Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205625

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ARNUITY ELLIPTA (FLUTICASONE FUROATE)
0.05MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE
Proprietary Name: ARNUITY ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.05MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205625
Product Number: 003
Approval Date: May 17, 2018
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

ARNUITY ELLIPTA (FLUTICASONE FUROATE)
0.1MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE
Proprietary Name: ARNUITY ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205625
Product Number: 001
Approval Date: Aug 20, 2014
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

ARNUITY ELLIPTA (FLUTICASONE FUROATE)
0.2MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE
Proprietary Name: ARNUITY ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.2MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205625
Product Number: 002
Approval Date: Aug 20, 2014
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information