Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021878
Company: NOVO NORDISK

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

Products on BLA 21878

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

Labels for BLA 021878

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/19/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021878lbl.pdf