Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020316
Company: GUERBET
Company: GUERBET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXILAN-300 | IOXILAN | 62% | INJECTABLE;INJECTION | Discontinued | None | No | No |
OXILAN-350 | IOXILAN | 73% | INJECTABLE;INJECTION | Discontinued | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/05/2017 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf | |
07/06/2015 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf |