Details for New Drug Application (NDA): 209382
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NDA 209382 describes TREPROSTINIL, which is a drug marketed by Alembic Global, Dr Reddys, Ph Health, Sandoz, and Teva Pharms Usa, and is included in five NDAs. It is available from four suppliers. Additional details are available on the TREPROSTINIL profile page.
The generic ingredient in TREPROSTINIL is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
The generic ingredient in TREPROSTINIL is treprostinil. There are nineteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
Summary for 209382
| Tradename: | TREPROSTINIL |
| Applicant: | Ph Health |
| Ingredient: | treprostinil |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 1MG/ML | ||||
| Approval Date: | Sep 24, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 2.5MG/ML | ||||
| Approval Date: | Sep 24, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 5MG/ML | ||||
| Approval Date: | Sep 24, 2019 | TE: | RLD: | No | |||||
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