Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203496

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ORENITRAM (TREPROSTINIL DIOLAMINE)
EQ 0.125MG BASE
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL DIOLAMINE
Proprietary Name: ORENITRAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 0.125MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203496
Product Number: 001
Approval Date: Dec 20, 2013
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ORENITRAM (TREPROSTINIL DIOLAMINE)
EQ 0.25MG BASE
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL DIOLAMINE
Proprietary Name: ORENITRAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 0.25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203496
Product Number: 002
Approval Date: Dec 20, 2013
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ORENITRAM (TREPROSTINIL DIOLAMINE)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL DIOLAMINE
Proprietary Name: ORENITRAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203496
Product Number: 003
Approval Date: Dec 20, 2013
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ORENITRAM (TREPROSTINIL DIOLAMINE)
EQ 2.5MG BASE
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL DIOLAMINE
Proprietary Name: ORENITRAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203496
Product Number: 004
Approval Date: Dec 20, 2013
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

ORENITRAM (TREPROSTINIL DIOLAMINE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL DIOLAMINE
Proprietary Name: ORENITRAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203496
Product Number: 005
Approval Date: Oct 7, 2016
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information