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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761060
Company: WYETH PHARMS INC

Products on BLA 761060

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761060

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.html
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.html

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

Labels for BLA 761060

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

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