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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020571
Company: PFIZER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2024 SUPPL-56 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020571Orig1s056lbl.pdf
01/27/2022 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020571Orig1s053lbl.pdf
01/30/2020 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020571s051lbl.pdf
02/22/2019 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020571s050lbl.pdf
12/19/2014 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf
07/13/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020571s042lbl.pdf
05/14/2010 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
05/14/2010 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
05/14/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
05/14/2010 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
05/14/2010 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf
08/01/2006 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020571s030lbl.pdf
07/21/2005 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
07/21/2005 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
07/21/2005 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf
06/07/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf
12/03/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571s023lbl.pdf
06/24/2004 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571se8-021_camptosar_lbl.pdf
05/16/2002 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf
04/20/2000 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20571s9lbl.pdf
10/22/1998 SUPPL-8 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf
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