Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 208157
Company: BAXTER HLTHCARE CORP

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 208157

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYXREDLIN	INSULIN HUMAN	100 UNITS/100ML (1 UNIT/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 208157

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208157s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208157Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208157Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/04/2020	SUPPL-2	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208157Orig1s002ltr.pdf

Labels for BLA 208157

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/20/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208157s000lbl.pdf