FdaApplication
NDA 210493
Identifiers
- fda_app_no: NDA210493
Properties
| Property | Value |
|---|---|
| applicant_name | HELSINN HEALTHCARE SA |
| application_type | NDA |
| approval_date | 2018-04-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| AKYNZEO | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE | EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | SOLUTION;INTRAVENOUS |
| AKYNZEO | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE | EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | POWDER;INTRAVENOUS |
2 products