Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020918
Company: NOVO NORDISK
Company: NOVO NORDISK
| 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| GLUCAGON HYDROCHLORIDE | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |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| GLUCAGON HYDROCHLORIDE | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Discontinued | None | Yes | No |
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.html |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020918Orig1s056ltr.pdf | |
| 03/11/2021 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020918Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020918Orig1s054ltr.pdf | |
| 09/03/2020 | SUPPL-53 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020918Orig1s053ltr.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, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
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 |
|---|---|---|---|---|---|
| 07/20/2021 | 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 |