Generic Companies with Tentative Approvals for: treprostinil
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treprostinil Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
United Therap | treprostinil | 021272 | 5MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
United Therap | treprostinil | 021272 | 10MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
United Therap | treprostinil | 021272 | 0.4MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
United Therap | treprostinil | 021272 | 0.2MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
United Therap | treprostinil | 021272 | 20MG/ML | INJECTABLE;IV (INFUSION), SUBCUTANEOUS |
United Therap | treprostinil | 021272 | 0.1MG/ML | INJECTABLE;IV (INFUSION), SUBCUTANEOUS |
Actavis Labs | treprostinil | 208906 | 0.125MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |