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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019959
Company: NOVO NORDISK INC

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

Products on BLA 19959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOVOLIN N	INSULIN SUSP ISOPHANE RECOMBINANT HUMAN	100 UNITS/ML	INJECTABLE;INJECTION	Over-the-counter	None	No	No

Labels for BLA 019959

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/23/2022	SUPPL-85	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019959s085lbl.pdf
11/23/2022	SUPPL-85	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019959s085lbl.pdf
11/23/2022	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019959s085lbl.pdf
11/15/2019	SUPPL-82	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019959s082lbl.pdf
11/15/2019	SUPPL-82	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019959s082lbl.pdf
06/01/2018	SUPPL-79	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019959s074s079lbl.pdf
06/01/2018	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019959s074s079lbl.pdf
01/08/2016	SUPPL-77	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019959s077lbl.pdf
02/25/2015	SUPPL-75	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019959s075lbl.pdf
03/09/2013	SUPPL-73	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019959s073lbl.pdf
03/09/2013	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019959s073lbl.pdf
07/17/2009	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
07/17/2009	SUPPL-67	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
06/15/2009	SUPPL-66	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf
04/15/2002	SUPPL-35	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf
04/11/2002	SUPPL-34	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf
04/11/2002	SUPPL-34	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf
03/11/2002	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf
12/19/2001	SUPPL-36	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19959s36lbl.pdf

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