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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020451
Company: PINNACLE BIOLGS

Products on NDA 020451

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020451

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.

Labels for NDA 020451

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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