FdaApplication
ANDA 091375
Identifiers
- fda_app_no: ANDA091375
Properties
| Property | Value |
|---|---|
| applicant_name | HIKMA FARMACEUTICA (PORTUGAL) SA |
| application_type | ANDA |
| approval_date | 2011-09-16 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) | INJECTABLE;INJECTION |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) | INJECTABLE;INJECTION |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) | INJECTABLE;INJECTION |
3 products