FdaApplication
NDA 021372
Identifiers
- fda_app_no: NDA021372
Properties
| Property | Value |
|---|---|
| applicant_name | HELSINN HEALTHCARE SA |
| application_type | NDA |
| approval_date | 2003-07-25 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ALOXI | PALONOSETRON HYDROCHLORIDE | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS |
| ALOXI | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAVENOUS |
2 products