FdaApplication
NDA 012209
Identifiers
- fda_app_no: NDA012209
Properties
| Property | Value |
|---|---|
| applicant_name | SPECTRUM PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2016-07-29 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
2 products