Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021525
Company: AXCAN SCANDIPHARM
Company: AXCAN SCANDIPHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHOTOFRIN | PORFIMER SODIUM | 75MG/VIAL | Injectable; Injection | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/01/2003 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20451s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020415s012_021525_PhotofrinTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/01/2020 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020451s029,021525s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020451Orig1s029, 021525Orig1s005ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/01/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020451s029,021525s005lbl.pdf | |
08/01/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf |