Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020451
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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