Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761060
Company: WYETH PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYLOTARG GEMTUZUMAB OZOGAMICIN 4.5MG VIAL;SINGLE-DOSE Prescription 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
09/01/2017 ORIG-2 Approval N/A; Orphan Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761060Orig1s000Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761060Orig1s000Orig1Orig2s000TOC.cfm
09/01/2017 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761060Orig1s000Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761060Orig1s000Orig1Orig2s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/2020 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761060Orig1s004ltr.pdf
02/27/2020 SUPPL-3 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761060Orig1s003ltr.pdf
04/09/2018 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761060s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761060Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2020 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s004lbl.pdf
02/27/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761060s003lbl.pdf
04/09/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761060s001lbl.pdf
09/01/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761060lbl.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