Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020451
Company: PINNACLE BIOLGS
Company: PINNACLE BIOLGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHOTOFRIN | PORFIMER SODIUM | 75MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
12/27/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020451Orig1s000rev.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/01/2020 | SUPPL-29 | 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 | |
06/24/2011 | SUPPL-23 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s023ltr.pdf | |
04/04/2011 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020451s020ltr.pdf | |
09/08/2008 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020451s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020451s019ltr.pdf | |
09/29/2005 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020451s016ltr.pdf |
07/19/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/01/2003 | SUPPL-12 | Labeling |
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 | |
09/25/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/08/2001 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/06/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/17/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/22/1998 | SUPPL-3 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451s3ltr.pdf |
01/09/1998 | SUPPL-2 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20451sap.pdf |
09/10/1996 | SUPPL-1 | 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 |
---|---|---|---|---|---|
01/01/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020451s029,021525s005lbl.pdf | |
06/24/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf | |
06/24/2011 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s023lbl.pdf | |
04/04/2011 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020451s020lbl.pdf | |
09/08/2008 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020451s019lbl.pdf | |
08/01/2003 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20451s012_photofrin_lbl.pdf |