Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016267
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESFERAL | DEFEROXAMINE MESYLATE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DESFERAL | DEFEROXAMINE MESYLATE | 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 09/09/2022 | SUPPL-62 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/016267s062lbl.pdf | |
| 12/16/2011 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016267s050lbl.pdf | |
| 09/07/2010 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016267s047lbl.pdf | |
| 01/28/2009 | SUPPL-45 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016267s045lbl.pdf | |
| 01/19/2007 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016267s044lbl.pdf |