Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 209482

Expand all

TRELEGY ELLIPTA (FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE)
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Proprietary Name: TRELEGY ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209482
Product Number: 001
Approval Date: Sep 18, 2017
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information

TRELEGY ELLIPTA (FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE)
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Proprietary Name: TRELEGY ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209482
Product Number: 002
Approval Date: Sep 9, 2020
Applicant Holder Full Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
Marketing Status:  Prescription
Patent and Exclusivity Information