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 |
| 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 |
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