FdaApplication
ANDA 091032
Identifiers
- fda_app_no: ANDA091032
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA FARMACEUTICA (PORTUGAL) SA |
| application_type | ANDA |
| approval_date | 2010-12-20 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION |
2 products