Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022555
Company: PHOTOCURE ASA
Company: PHOTOCURE ASA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYSVIEW KIT | HEXAMINOLEVULINATE HYDROCHLORIDE | 100MG/VIAL | FOR SOLUTION;INTRAVESICAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2018 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf | |
| 07/29/2016 | SUPPL-4 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf |
| 05/28/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf |