FdaApplication
ANDA 213278
Identifiers
- fda_app_no: ANDA213278
Properties
| Property | Value |
|---|---|
| applicant_name | EUGIA PHARMA SPECIALITIES LTD |
| application_type | ANDA |
| approval_date | 2020-11-02 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 300MG/15ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION |
4 products