FdaApplication
NDA 020635
Identifiers
- fda_app_no: NDA020635
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1996-12-20 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| LEVAQUIN | LEVOFLOXACIN | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LEVAQUIN | LEVOFLOXACIN | EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
5 products