FdaApplication
NDA 202799
Identifiers
- fda_app_no: NDA202799
Properties
| Property | Value |
|---|---|
| applicant_name | TAKEDA PHARMACEUTICALS USA INC |
| application_type | NDA |
| approval_date | 2012-03-27 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OMONTYS | PEGINESATIDE ACETATE | EQ 10MG BASE/ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS | PEGINESATIDE ACETATE | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
| OMONTYS PRESERVATIVE FREE | PEGINESATIDE ACETATE | EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) | SOLUTION;INTRAVENOUS, SUBCUTANEOUS |
8 products