Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761060
Company: WYETH PHARMS INC
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 |