Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021433

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FLOVENT HFA (FLUTICASONE PROPIONATE)
0.044MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: FLOVENT HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.044MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021433
Product Number: 003
Approval Date: May 14, 2004
Applicant Holder Full Name: GLAXO GROUP LTD DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

FLOVENT HFA (FLUTICASONE PROPIONATE)
0.11MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: FLOVENT HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.11MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021433
Product Number: 002
Approval Date: May 14, 2004
Applicant Holder Full Name: GLAXO GROUP LTD DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

FLOVENT HFA (FLUTICASONE PROPIONATE)
0.22MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: FLOVENT HFA
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.22MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021433
Product Number: 001
Approval Date: May 14, 2004
Applicant Holder Full Name: GLAXO GROUP LTD DBA GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information