Application 020087
- Type
- NDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLOXIN IN DEXTROSE 5% | OFLOXACIN | INJECTABLE;INJECTION | 400MG/100ML | No | No |
| 002 | FLOXIN | OFLOXACIN | INJECTABLE;INJECTION | 20MG/ML | No | No |
| 003 | FLOXIN | OFLOXACIN | INJECTABLE;INJECTION | 40MG/ML | No | No |
| 004 | FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | OFLOXACIN | INJECTABLE;INJECTION | 4MG/ML | No | No |
| 005 | FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | OFLOXACIN | INJECTABLE;INJECTION | 400MG/100ML | No | No |