Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020986
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOVOLOG | INSULIN ASPART RECOMBINANT | 1000 UNITS/10ML (100 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| NOVOLOG FLEXPEN | INSULIN ASPART RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| NOVOLOG FLEXTOUCH | INSULIN ASPART RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| NOVOLOG INNOLET | INSULIN ASPART RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| NOVOLOG PENFILL | INSULIN ASPART RECOMBINANT | 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2023 | SUPPL-96 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020986s096lbl.pdf | |
| 02/28/2023 | SUPPL-96 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020986s096lbl.pdf | |
| 02/28/2023 | SUPPL-96 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020986s096lbl.pdf | |
| 10/22/2021 | SUPPL-95 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020986Orig1s095lbl.pdf | |
| 03/23/2021 | SUPPL-93 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020986s093lbl.pdf | |
| 03/23/2021 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020986s093lbl.pdf | |
| 11/15/2019 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf | |
| 11/15/2019 | SUPPL-90 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf | |
| 11/15/2019 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf | |
| 03/16/2017 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020986Orig1s079Lbledt.pdf | |
| 10/07/2016 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf | |
| 04/17/2015 | SUPPL-82 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf | |
| 02/25/2015 | SUPPL-81 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf | |
| 02/25/2015 | SUPPL-59 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf | |
| 01/23/2015 | SUPPL-80 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf | |
| 01/14/2015 | SUPPL-78 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf | |
| 10/31/2013 | SUPPL-61 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf | |
| 03/09/2013 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf | |
| 03/09/2013 | SUPPL-67 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf | |
| 12/13/2012 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf | |
| 11/05/2012 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf | |
| 07/17/2009 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf | |
| 07/17/2009 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf | |
| 07/17/2009 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf | |
| 07/17/2009 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf | |
| 07/14/2009 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf | |
| 07/14/2009 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf | |
| 03/14/2008 | SUPPL-47 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf | |
| 01/26/2007 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf | |
| 10/27/2006 | SUPPL-40 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf |
| 10/21/2005 | SUPPL-32 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf | |
| 09/13/2005 | SUPPL-33 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf | |
| 10/08/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf | |
| 07/30/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf | |
| 04/23/2004 | SUPPL-23 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf | |
| 03/19/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf | |
| 12/04/2002 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf | |
| 04/11/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf | |
| 04/11/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf | |
| 12/21/2001 | SUPPL-3 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf | |
| 06/07/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf |