Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203649

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

Active Ingredient: TREPROSTINIL
Proprietary Name: TREPROSTINIL
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 1MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203649
Product Number: 001
Approval Date: Nov 30, 2017
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TREPROSTINIL
Proprietary Name: TREPROSTINIL
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 2.5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203649
Product Number: 002
Approval Date: Nov 30, 2017
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TREPROSTINIL
Proprietary Name: TREPROSTINIL
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 5MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203649
Product Number: 003
Approval Date: Nov 30, 2017
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: TREPROSTINIL
Proprietary Name: TREPROSTINIL
Dosage Form; Route of Administration: INJECTABLE; IV (INFUSION), SUBCUTANEOUS
Strength: 10MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203649
Product Number: 004
Approval Date: Nov 30, 2017
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information