Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021077

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ADVAIR DISKUS 100/50 (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.1MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR DISKUS 100/50
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021077
Product Number: 001
Approval Date: Aug 24, 2000
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

ADVAIR DISKUS 250/50 (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.25MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR DISKUS 250/50
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.25MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021077
Product Number: 002
Approval Date: Aug 24, 2000
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

ADVAIR DISKUS 500/50 (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.5MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: ADVAIR DISKUS 500/50
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.5MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021077
Product Number: 003
Approval Date: Aug 24, 2000
Applicant Holder Full Name: GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information