FdaApplication
ANDA 078764
Identifiers
- fda_app_no: ANDA078764
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA FARMACEUTICA (PORTUGAL) SA |
| application_type | ANDA |
| approval_date | 2012-01-30 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION |
| FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/ML) | INJECTABLE;INJECTION |
2 products