Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021272

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REMODULIN (TREPROSTINIL)
0.1MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 0.1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021272
Product Number: 006
Approval Date: Sep 28, 2023
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
0.2MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 0.2MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021272
Product Number: 007
Approval Date: Sep 28, 2023
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
0.4MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 0.4MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021272
Product Number: 008
Approval Date: Sep 28, 2023
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
1MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021272
Product Number: 001
Approval Date: May 21, 2002
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
2.5MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 2.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021272
Product Number: 002
Approval Date: May 21, 2002
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
5MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021272
Product Number: 003
Approval Date: May 21, 2002
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
10MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 10MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021272
Product Number: 004
Approval Date: May 21, 2002
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

REMODULIN (TREPROSTINIL)
20MG/ML
Marketing Status: Prescription

Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 20MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021272
Product Number: 005
Approval Date: Jul 30, 2021
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information