Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761033
Company: TEVA RESPIRATORY LLC

• Summary Review

Products on BLA 761033

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CINQAIR	RESLIZUMAB	100MG/10ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761033

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761033Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761033Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761033Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/09/2019	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0761033s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761033Orig1s010ltr.pdf

Labels for BLA 761033

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/09/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/0761033s010lbl.pdf
03/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf