Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761169
Company: REGENERON PHARMACEUTICALS

Products on BLA 761169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INMAZEB	ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB	16.7MG/1ML	SOLUTION; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761169s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761169Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761169Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2022	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761169s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761169Orig1s003ltr.pdf
09/29/2021	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761169Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761169Orig1s002ltr.pdf

Labels for BLA 761169

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2022	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761169s003lbl.pdf
09/29/2021	SUPPL-2	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761169Orig1s002lbl.pdf
10/14/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761169s000lbl.pdf