Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021254

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ADVAIR HFA (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.045MG/INH;EQ 0.021MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.045MG/INH;EQ 0.021MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021254
Product Number: 001
Approval Date: Jun 8, 2006
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

ADVAIR HFA (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.115MG/INH;EQ 0.021MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.115MG/INH;EQ 0.021MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021254
Product Number: 002
Approval Date: Jun 8, 2006
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

ADVAIR HFA (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.23MG/INH;EQ 0.021MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.23MG/INH;EQ 0.021MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021254
Product Number: 003
Approval Date: Jun 8, 2006
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information