Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214324

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TYVASO DPI (TREPROSTINIL)
0.016MG/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: TYVASO DPI
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.016MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214324
Product Number: 001
Approval Date: May 23, 2022
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

TYVASO DPI (TREPROSTINIL)
0.032MG/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: TYVASO DPI
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.032MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214324
Product Number: 002
Approval Date: May 23, 2022
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

TYVASO DPI (TREPROSTINIL)
0.048MG/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: TYVASO DPI
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.048MG/INH
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214324
Product Number: 003
Approval Date: May 23, 2022
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

TYVASO DPI (TREPROSTINIL)
0.064MG/INH
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: TYVASO DPI
Dosage Form; Route of Administration: POWDER; INHALATION
Strength: 0.064MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214324
Product Number: 004
Approval Date: May 23, 2022
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information