Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208798

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ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE)
0.055MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.055MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 004
Approval Date: Feb 20, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE)
0.113MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.113MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 005
Approval Date: Feb 20, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE)
0.232MG/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.232MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208798
Product Number: 006
Approval Date: Feb 20, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARMONAIR DIGIHALER (FLUTICASONE PROPIONATE)
0.03MG/INH
Marketing Status: Discontinued

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.03MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 008
Approval Date: Apr 8, 2022
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARMONAIR RESPICLICK (FLUTICASONE PROPIONATE)
0.03MG/INH
Marketing Status: Discontinued

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.03MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 007
Approval Date: Jul 9, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARMONAIR RESPICLICK (FLUTICASONE PROPIONATE)
0.055MG/INH
Marketing Status: Discontinued

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.055MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 001
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARMONAIR RESPICLICK (FLUTICASONE PROPIONATE)
0.113MG/INH
Marketing Status: Discontinued

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.113MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 002
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

ARMONAIR RESPICLICK (FLUTICASONE PROPIONATE)
0.232MG/INH
Marketing Status: Discontinued

Active Ingredient: FLUTICASONE PROPIONATE
Proprietary Name: ARMONAIR RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.232MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208798
Product Number: 003
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information