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 |
| 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 |