Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021174
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYLOTARG GEMTUZUMAB OZOGAMICIN 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21174ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21174_Mylotorg.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2005 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s024ltr.pdf
06/14/2005 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021174s021ltr.pdf
01/23/2006 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021174s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021174s020ltr.pdf
07/23/2004 SUPPL-15 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174s015ltr.pdf
06/23/2004 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174slr014ltr.pdf
04/16/2004 SUPPL-12 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21174se8-012ltr.pdf
08/23/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/2001 SUPPL-4 Labeling

Label is not available on this site.

02/23/2001 SUPPL-2 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21174s2lbl.pdf
10/27/2000 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
01/23/2006 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021174s020lbl.pdf
02/23/2001 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21174s2lbl.pdf
05/17/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21174lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English