Drugs@FDA: FDA Approved Drug Products

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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
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
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
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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