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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021810
Company: NOVO NORDISK INC

Summary Review

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

Products on BLA 021810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOVOLOG MIX 50/50	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	50 UNITS/ML;50 UNITS/ML	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021810

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2008	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021810s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810_novolog_mix_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021810S000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2019	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
11/15/2019	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf
08/07/2019	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021810Orig1s017ltr.pdf
02/11/2019	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021810Orig1s015ltr.pdf
02/25/2015	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021810Orig1s010ltr.pdf
09/04/2014	SUPPL-8	Supplement		Label is not available on this site.
03/09/2013	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021810Orig1s004ltr.pdf
11/21/2017	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf

Labels for BLA 021810

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf
11/15/2019	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf
11/15/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810ss018s019lbl.pdf
08/07/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s017lbl.pdf
02/11/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021810s015lbl.pdf
11/21/2017	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021810s000lbl.pdf
02/25/2015	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf
03/09/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf
03/09/2013	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf
08/26/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021810lbl.pdf

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