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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/07/2000 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20986ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-986_NovoLog.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2023 | SUPPL-96 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020986s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020986Orig1s096ltr.pdf | |
| 10/22/2021 | SUPPL-95 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020986Orig1s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020986Orig1s095ltr.pdf | |
| 03/23/2021 | SUPPL-93 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020986s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020986Orig1s093ltr.pdf | |
| 11/15/2019 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
| 11/15/2019 | SUPPL-90 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020986s090s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
| 12/20/2018 | SUPPL-87 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020986s087lbl.pdf |
| 10/07/2016 | SUPPL-84 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020986s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020986Orig1s084ltr.pdf | |
| 04/17/2015 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s082ltr.pdf | |
| 02/25/2015 | SUPPL-81 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf | |
| 01/23/2015 | SUPPL-80 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s080ltr.pdf | |
| 03/16/2017 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020986Orig1s079Lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020986Orig1s079Ltredt.pdf | |
| 01/14/2015 | SUPPL-78 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s078ltr.pdf | |
| 09/04/2014 | SUPPL-77 | Supplement |
Label is not available on this site. |
||
| 09/04/2014 | SUPPL-76 | Supplement |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-75 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020986Orig1s075ltr.pdf |
| 03/04/2014 | SUPPL-74 | Supplement |
Label is not available on this site. |
||
| 03/09/2013 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s067ltr.pdf | |
| 12/13/2012 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s064ltr.pdf | |
| 11/28/2012 | SUPPL-62 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s062ltr.pdf |
| 10/31/2013 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020986s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020986Orig1s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020986Orig1s061.pdf | |
| 06/25/2010 | SUPPL-60 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf |
| 02/25/2015 | SUPPL-59 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020986Orig1s059,s081ltr.pdf | |
| 06/25/2010 | SUPPL-58 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s067,s069,019959s069,s071,019991s070,072,020986s058,s060ltr.pdf |
| 11/05/2012 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020986Orig1s057ltr.pdf | |
| 07/17/2009 | SUPPL-55 | Supplement |
Label (PDF)
Label (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s064,019959s067,019991s068,020986s055ltr.pdf | |
| 05/07/2009 | SUPPL-54 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s054ltr.pdf |
| 11/28/2008 | SUPPL-53 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021536s023,020986s053,021172s043ltr.pdf |
| 09/03/2008 | SUPPL-50 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf |
| 09/03/2008 | SUPPL-49 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf |
| 03/14/2008 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020986Orig1s047.pdf | |
| 07/14/2009 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020986s045ltr.pdf | |
| 10/27/2006 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020986s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020986s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020986Orig1s040.pdf | |
| 01/26/2007 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020986s037ltr.pdf | |
| 09/13/2005 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020986s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020986s033ltr.pdf | |
| 10/21/2005 | SUPPL-32 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20986s032lbl.pdf | |
| 07/30/2004 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s024ltr.pdf | |
| 04/23/2004 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986scp023ltr.pdf | |
| 03/19/2004 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986slr020_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986slr020ltr.pdf | |
| 10/08/2004 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20986s019,21172s013ltr.pdf | |
| 12/04/2002 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 11/19/2002 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 12/04/2002 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986se8-011ltr.pdf | |
| 07/29/2002 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 03/05/2002 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 11/20/2001 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 08/31/2001 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 06/26/2001 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s4ltr.pdf | |
| 12/21/2001 | SUPPL-3 | Supplement |
Label (PDF)
Review Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986se3003_Novolog.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_Approv.pdf | |
| 04/11/2002 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20986s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020986Orig1s002.pdf | |
| 01/19/2001 | SUPPL-1 | Supplement |
Label is not available on this site. |
| 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 |