FdaApplication
ANDA 203380
Identifiers
- fda_app_no: ANDA203380
Properties
| Property | Value |
|---|---|
| applicant_name | QILU PHARMACEUTICAL HAINAN CO LTD |
| application_type | ANDA |
| approval_date | 2016-05-03 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 300MG/15ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION |
3 products