Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/14/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2014 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020571Orig1s048ltr.pdf
06/09/2014 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/17/2013 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

07/13/2012 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020571s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020571Orig1s042ltr.pdf
05/14/2010 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf
05/14/2010 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf
05/14/2010 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf
05/14/2010 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf
05/14/2010 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020571s031s032s033s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020571s031,s032,s033,s036,s037ltr.pdf
08/01/2006 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020571s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020571s030LTR.pdf
07/21/2005 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf
07/21/2005 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf
06/07/2005 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s026ltr.pdf
07/21/2005 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020571s024,027,028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf
12/03/2004 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20571s023ltr.pdf
06/24/2004 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20571se8-021_camptosar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20571se8-021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-571s021_Camptosar.cfm
07/30/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/16/2002 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20571s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20571s016ltr.pdf
11/05/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/20/2000 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20571s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20571s9ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20571-S009_Camptosar.cfm
10/22/1998 SUPPL-8 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20571s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20571s8ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571s008.cfm
03/18/1998 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571_S007_CAPTOSAR_AP.pdf
01/15/1998 SUPPL-6 Manufacturing (CMC)-Formulation Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020571_S006_CAPTOSAR_AP.pdf
10/21/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/1997 SUPPL-4 Labeling

Label is not available on this site.

06/05/1997 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1997 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

CAMPTOSAR

INJECTABLE;INJECTION; 40MG/2ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020571 PFIZER INC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 079068 ACCORD HLTHCARE
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078589 ACTAVIS TOTOWA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090726 AKORN
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077219 CIPLA LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078953 DR REDDYS LABS LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 200771 EMCURE PHARMS LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078188 FRESENIUS KABI ONCOL
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077776 FRESENIUS KABI USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 091032 HIKMA FARMACEUTICA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090016 HISUN PHARM HANGZHOU
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077915 HOSPIRA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206935 INGENUS PHARMS LLC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203054 INTAS PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090675 JIANGSU HENGRUI MED
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090393 MUSTAFA NEVZAT ILAC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078122 PLIVA LACHEMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078805 SUN PHARMA GLOBAL
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090101 TEVA PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078753 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 100MG/5ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020571 PFIZER INC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 079068 ACCORD HLTHCARE
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078589 ACTAVIS TOTOWA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090726 AKORN
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077219 CIPLA LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078953 DR REDDYS LABS LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 200771 EMCURE PHARMS LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078188 FRESENIUS KABI ONCOL
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077776 FRESENIUS KABI USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 091032 HIKMA FARMACEUTICA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090016 HISUN PHARM HANGZHOU
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 077915 HOSPIRA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 206935 INGENUS PHARMS LLC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203054 INTAS PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090675 JIANGSU HENGRUI MED
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090393 MUSTAFA NEVZAT ILAC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078122 PLIVA LACHEMA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078805 SUN PHARMA GLOBAL
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 090101 TEVA PHARMS USA
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 078753 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 300MG/15ML (20MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CAMPTOSAR IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020571 PFIZER INC
IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) INJECTABLE;INJECTION Prescription No AP 203380 QILU PHARM CO LTD

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