Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012209
Company: SPECTRUM PHARMS
Company: SPECTRUM PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOROURACIL | FLUOROURACIL | 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2016 | SUPPL-40 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf |