Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 210605
Company: MYLAN PHARMS INC

• This Former NDA Was Deemed To Be a BLA

Products on BLA 210605

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEMGLEE	INSULIN GLARGINE	100 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 210605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/11/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review	This Former NDA Was Deemed To Be a BLA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210605s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210605Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210605Orig1s000TOC.cfm

Labels for BLA 210605

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/11/2020	ORIG-1	Approval	Label (PDF)	This Former NDA Was Deemed To Be a BLA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210605s000lbl.pdf