FdaApplication
ANDA 211574
Identifiers
- fda_app_no: ANDA211574
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC GLOBAL HOLDING SA |
| application_type | ANDA |
| approval_date | 2021-02-11 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TREPROSTINIL | TREPROSTINIL | 2.5MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
| TREPROSTINIL | TREPROSTINIL | 5MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
| TREPROSTINIL | TREPROSTINIL | 10MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
| TREPROSTINIL | TREPROSTINIL | 1MG/ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
4 products