U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 208276

Expand all

REMODULIN (TREPROSTINIL)
20MG/20ML (1MG/ML)
Marketing Status: Discontinued
Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: 20MG/20ML (1MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N208276
Product Number: 001
Approval Date: Jul 30, 2018
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
REMODULIN (TREPROSTINIL)
50MG/20ML (2.5MG/ML)
Marketing Status: Discontinued
Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: 50MG/20ML (2.5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N208276
Product Number: 002
Approval Date: Jul 30, 2018
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
REMODULIN (TREPROSTINIL)
100MG/20ML (5MG/ML)
Marketing Status: Discontinued
Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N208276
Product Number: 003
Approval Date: Jul 30, 2018
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
REMODULIN (TREPROSTINIL)
200MG/20ML (10MG/ML)
Marketing Status: Discontinued
Active Ingredient: TREPROSTINIL
Proprietary Name: REMODULIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, SUBCUTANEOUS
Strength: 200MG/20ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N208276
Product Number: 004
Approval Date: Jul 30, 2018
Applicant Holder Full Name: UNITED THERAPEUTICS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top