Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018489
Company: DRAXIMAGE
Company: DRAXIMAGE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNESCAN HIDA | TECHNETIUM TC-99M LIDOFENIN KIT | N/A | INJECTABLE;INJECTION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/29/2013 | SUPPL-52 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018469s052lbl.pdf |