اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYSVIEW KIT از شرکت PHOTOCURE ASA
New Drug Application (NDA): 022555
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/28/2010 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf |
Supplements
| 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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022555s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022555Orig1s005ltr.pdf |
||
| 07/29/2016 | SUPPL-4 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022555s004lbl.pdf |
||
| 11/28/2012 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
| 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 |
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