Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 204275

Expand all

BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE)
0.05MG/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Proprietary Name: BREO ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.05MG/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204275
Product Number: 003
Approval Date: May 12, 2023
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE)
0.1MG/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Proprietary Name: BREO ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204275
Product Number: 001
Approval Date: May 10, 2013
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE)
0.2MG/INH;EQ 0.025MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
Proprietary Name: BREO ELLIPTA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.2MG/INH;EQ 0.025MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204275
Product Number: 002
Approval Date: Apr 30, 2015
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information