FdaApplication
ANDA 205648
Identifiers
- fda_app_no: ANDA205648
Properties
| Property | Value |
|---|---|
| applicant_name | QILU PHARMACEUTICAL HAINAN CO LTD |
| application_type | ANDA |
| approval_date | 2018-09-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS |
| PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) | INJECTABLE;INTRAVENOUS |
2 products