Product Details for ANDA 213948
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
0.1MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
0.25MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
0.5MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
0.1MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 001
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.1MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 001
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
0.25MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.25MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 002
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE)
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.25MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 002
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
0.5MG/INH;EQ 0.05MG BASE/INH
Marketing Status: Prescription
Active Ingredient: FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.5MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 003
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.5MG/INH;EQ 0.05MG BASE/INH
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213948
Product Number: 003
Approval Date: Dec 13, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information