Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 208799

Expand all

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;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;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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English