Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208799

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AIRDUO DIGIHALER (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.055MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.055MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208799
Product Number: 004
Approval Date: Jul 12, 2019
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AIRDUO DIGIHALER (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.113MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.113MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208799
Product Number: 005
Approval Date: Jul 12, 2019
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AIRDUO DIGIHALER (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.232MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO DIGIHALER
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.232MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208799
Product Number: 006
Approval Date: Jul 12, 2019
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.055MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.055MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208799
Product Number: 001
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.113MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.113MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208799
Product Number: 002
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.232MG/INH;EQ 0.014MG BASE/INH
Marketing Status: Prescription

Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: AIRDUO RESPICLICK
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.232MG/INH;EQ 0.014MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208799
Product Number: 003
Approval Date: Jan 27, 2017
Applicant Holder Full Name: TEVA PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information