Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020571
Company: PFIZER INC
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 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020571Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020571Orig1s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020571Orig1s053ltr.pdf | |
| 01/27/2022 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2020 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020571s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020571Orig1s051ltr.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)
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 |
|---|---|---|---|---|---|
| 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 |
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 | EPIC PHARMA LLC |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213278 | EUGIA PHARMA |
| 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 | 212993 | GLAND PHARMA LTD |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090675 | HENGRUI PHARMA |
| 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 | 203054 | INTAS PHARMS USA |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206935 | NOVAST LABS |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203380 | QILU PHARM HAINAN |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208718 | SHILPA |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078753 | WEST-WARD PHARMS INT |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090393 | ZENNOVA |
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 | EPIC PHARMA LLC |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213278 | EUGIA PHARMA |
| 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 | 212993 | GLAND PHARMA LTD |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090675 | HENGRUI PHARMA |
| 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 | 203054 | INTAS PHARMS USA |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206935 | NOVAST LABS |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203380 | QILU PHARM HAINAN |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208718 | SHILPA |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078753 | WEST-WARD PHARMS INT |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090393 | ZENNOVA |
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 | 213278 | EUGIA PHARMA |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 300MG/15ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203380 | QILU PHARM HAINAN |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 300MG/15ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 208718 | SHILPA |