Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213005

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YUTREPIA (TREPROSTINIL SODIUM)
EQ 0.0265MG BASE/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL SODIUM
Proprietary Name: YUTREPIA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.0265MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213005
Product Number: 001
Approval Date: May 23, 2025
Applicant Holder Full Name: LIQUIDIA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

YUTREPIA (TREPROSTINIL SODIUM)
EQ 0.053MG BASE/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL SODIUM
Proprietary Name: YUTREPIA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.053MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213005
Product Number: 002
Approval Date: May 23, 2025
Applicant Holder Full Name: LIQUIDIA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

YUTREPIA (TREPROSTINIL SODIUM)
EQ 0.0795MG BASE/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL SODIUM
Proprietary Name: YUTREPIA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.0795MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213005
Product Number: 003
Approval Date: May 23, 2025
Applicant Holder Full Name: LIQUIDIA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

YUTREPIA (TREPROSTINIL SODIUM)
EQ 0.106MG BASE/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL SODIUM
Proprietary Name: YUTREPIA
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: EQ 0.106MG BASE/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213005
Product Number: 004
Approval Date: May 23, 2025
Applicant Holder Full Name: LIQUIDIA TECHNOLOGIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information