Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020918
Company: NOVO NORDISK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCAGEN GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/22/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20918lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20918_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020918s000_GlucagenTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020918Orig1s049ltr.pdf
02/11/2016 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/10/2015 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020918s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020918Orig1s043ltr.pdf
03/14/2014 SUPPL-42 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020918Orig1s042ltr.pdf
04/26/2013 SUPPL-40 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020918Orig1s040ltr.pdf
04/26/2013 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

01/16/2013 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/29/2011 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020918s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020918s034ltr.pdf
12/15/2010 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020918s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020918s030ltr.pdf
06/28/2007 SUPPL-23 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/14/2005 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020918s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020918s017ltr.pdf
12/23/2004 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918s012ltr.pdf
03/01/2004 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20918slr008_glucagen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20918slr008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020918_S008_GLUCAGEN.pdf
08/05/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2002 SUPPL-3 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20918slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020918_S003_GLUCAGEN.pdf
08/18/2000 SUPPL-2 Labeling

Label is not available on this site.

05/30/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020918s049lbl.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
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

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