Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020918
Company: NOVO NORDISK

Products on NDA 20918

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	POWDER;INTRAMUSCULAR, INTRAVENOUS	Discontinued	None	Yes	No
GLUCAGEN	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Discontinued	None	Yes	No

Labels for NDA 020918

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2021	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918s056lbl.pdf
03/11/2021	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918Orig1s054lbl.pdf
07/06/2018	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s052lbl.pdf
04/18/2018	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf
04/18/2018	SUPPL-49	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf
04/18/2018	SUPPL-49	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf
12/10/2015	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf
12/29/2011	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf
12/15/2010	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020918s030lbl.pdf
11/14/2005	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020918s017lbl.pdf
12/23/2004	SUPPL-12	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf
03/01/2004	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918slr008_glucagen_lbl.pdf
06/22/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf