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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761172
Company: RIDGEBACK BIOTHERAPEUTICS

Products on BLA 761172

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EBANGA	ANSUVIMAB-ZYKL	400MG/VIAL	POWDER;IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761172

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761172s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761172Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761172Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2022	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761172Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761172Orig1s004ltr.pdf
12/07/2021	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761172s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761172Orig1s002ltr.pdf

Labels for BLA 761172

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761172Orig1s004lbl.pdf
12/07/2021	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761172s002lbl.pdf
12/07/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761172s002lbl.pdf
12/21/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761172s000lbl.pdf

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