Product Details for ANDA 211574
TREPROSTINIL (TREPROSTINIL)
1MG/ML
Marketing Status: Prescription
2.5MG/ML
Marketing Status: Prescription
5MG/ML
Marketing Status: Prescription
10MG/ML
Marketing Status: Prescription
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: A211574
Product Number: 001
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
TREPROSTINIL (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: A211574
Product Number: 001
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
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: A211574
Product Number: 002
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
TREPROSTINIL (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: A211574
Product Number: 002
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
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: A211574
Product Number: 003
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
TREPROSTINIL (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: A211574
Product Number: 003
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
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: A211574
Product Number: 004
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information
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: A211574
Product Number: 004
Approval Date: Feb 11, 2021
Applicant Holder Full Name: ALEMBIC GLOBAL HOLDING SA
Marketing Status: Prescription
Patent and Exclusivity Information