Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021172
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOVOLOG MIX 70/30 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| NOVOLOG MIX 70/30 FLEXPEN | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Prescription | None | No | No |
| NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| NOVOLOG MIX 70/30 PENFILL | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | 210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) | INJECTABLE;SUBCUTANEOUS | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 11/01/2001 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/28/2023 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021172s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021172Orig1s076ltr.pdf | |
| 04/28/2021 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021172s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021172Orig1s074ltr.pdf | |
| 11/15/2019 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
| 11/15/2019 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020986Orig1s090, s091; 021810Orig1s018, s019; 021172Orig1s071, s072ltr.pdf | |
| 12/20/2018 | SUPPL-68 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021172s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021172Orig1s068Ltr.pdf | |
| 04/17/2015 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s064ltr.pdf | |
| 02/25/2015 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf | |
| 05/08/2017 | SUPPL-62 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021172s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021172Orig1s062ltr.pdf | |
| 09/04/2014 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
| 03/09/2013 | SUPPL-53 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021172Orig1s053ltr.pdf | |
| 12/13/2012 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021172Orig1s051ltr.pdf | |
| 05/07/2010 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf | |
| 02/25/2015 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021172Orig1s046,s063ltr.pdf | |
| 05/07/2010 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021172s045,s049ltr.pdf | |
| 05/07/2009 | SUPPL-44 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021172s044,021536s024ltr.pdf |
| 11/28/2008 | SUPPL-43 | 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-39 | 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-38 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020986s049s050021172s038s039021536s020s021ltr.pdf |
| 07/20/2007 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021172s034ltr.pdf | |
| 11/14/2005 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s023ltr.pdf | |
| 11/21/2005 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021172s021ltr.pdf | |
| 10/08/2004 | SUPPL-13 | 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-11 | Supplement |
Label is not available on this site. |
||
| 11/19/2002 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 11/18/2002 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172scp009ltr.pdf | |
| 07/29/2002 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 03/05/2002 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 02/25/2002 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 02/25/2002 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 02/25/2002 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 06/26/2002 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172s003ltr.pdf | |
| 02/25/2002 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21172S001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2023 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021172s076lbl.pdf | |
| 02/28/2023 | SUPPL-76 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021172s076lbl.pdf | |
| 02/28/2023 | SUPPL-76 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021172s076lbl.pdf | |
| 04/28/2021 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021172s074lbl.pdf | |
| 04/28/2021 | SUPPL-74 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021172s074lbl.pdf | |
| 11/15/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf | |
| 11/15/2019 | SUPPL-71 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf | |
| 11/15/2019 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021172s071s072lbl.pdf | |
| 12/20/2018 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021172s068lbl.pdf | |
| 05/08/2017 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021172s062lbl.pdf | |
| 04/17/2015 | SUPPL-64 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s064lbl.pdf | |
| 02/25/2015 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf | |
| 02/25/2015 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021172s046s063lbl.pdf | |
| 03/09/2013 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf | |
| 03/09/2013 | SUPPL-53 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf | |
| 12/13/2012 | SUPPL-51 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf | |
| 05/07/2010 | SUPPL-49 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf | |
| 05/07/2010 | SUPPL-45 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf | |
| 07/20/2007 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf | |
| 07/20/2007 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021172s034lbl.pdf | |
| 11/21/2005 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf | |
| 11/14/2005 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s023lbl.pdf | |
| 10/08/2004 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf | |
| 11/18/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172scp009_novolog_lbl.pdf | |
| 06/26/2002 | SUPPL-3 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf | |
| 05/03/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s1lbl.pdf | |
| 11/01/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21172_Novolog_prntlbl.pdf |