Details for New Drug Application (NDA): 203649
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The generic ingredient in TREPROSTINIL is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 203649
Tradename: | TREPROSTINIL |
Applicant: | Sandoz |
Ingredient: | treprostinil |
Patents: | 0 |
Pharmacology for NDA: 203649
Physiological Effect | Vasodilation |
Suppliers and Packaging for NDA: 203649
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 203649 | ANDA | Sandoz Inc | 0781-3420 | 0781-3420-80 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3420-80) / 20 mL in 1 VIAL, MULTI-DOSE |
TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 203649 | ANDA | Sandoz Inc | 0781-3425 | 0781-3425-80 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) / 20 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | Strength | 1MG/ML | ||||
Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | Strength | 2.5MG/ML | ||||
Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | Strength | 5MG/ML | ||||
Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No |
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