Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020986
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
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

Label is not available on this site.

10/07/2016 SUPPL-84 Supplement

Label is not available on this site.

04/17/2015 SUPPL-82 Supplement

Label is not available on this site.

02/25/2015 SUPPL-81 Supplement

Label is not available on this site.

01/23/2015 SUPPL-80 Supplement

Label is not available on this site.

03/16/2017 SUPPL-79 Supplement

Label is not available on this site.

01/14/2015 SUPPL-78 Supplement

Label is not available on this site.

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

Label is not available on this site.

03/04/2014 SUPPL-74 Supplement

Label is not available on this site.

03/09/2013 SUPPL-67 Supplement

Label is not available on this site.

12/13/2012 SUPPL-64 Supplement

Label is not available on this site.

11/28/2012 SUPPL-62 Supplement

Label is not available on this site.

10/31/2013 SUPPL-61 Supplement

Label is not available on this site.

06/25/2010 SUPPL-60 Supplement

Label is not available on this site.

02/25/2015 SUPPL-59 Supplement

Label is not available on this site.

06/25/2010 SUPPL-58 Supplement

Label is not available on this site.

11/05/2012 SUPPL-57 Supplement

Label is not available on this site.

07/17/2009 SUPPL-55 Supplement

Label is not available on this site.

05/07/2009 SUPPL-54 Supplement

Label is not available on this site.

11/28/2008 SUPPL-53 Supplement

Label is not available on this site.

09/03/2008 SUPPL-50 Supplement

Label is not available on this site.

09/03/2008 SUPPL-49 Supplement

Label is not available on this site.

03/14/2008 SUPPL-47 Supplement

Label is not available on this site.

07/14/2009 SUPPL-45 Supplement

Label is not available on this site.

10/27/2006 SUPPL-40 Supplement

Label is not available on this site.

01/26/2007 SUPPL-37 Supplement

Label is not available on this site.

09/13/2005 SUPPL-33 Supplement

Label is not available on this site.

10/21/2005 SUPPL-32 Supplement

Label is not available on this site.

07/30/2004 SUPPL-24 Supplement

Label is not available on this site.

04/23/2004 SUPPL-23 Supplement

Label is not available on this site.

03/19/2004 SUPPL-20 Supplement

Label is not available on this site.

10/08/2004 SUPPL-19 Supplement

Label is not available on this site.

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 is not available on this site.

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 is not available on this site.

12/21/2001 SUPPL-3 Supplement

Label is not available on this site.

04/11/2002 SUPPL-2 Supplement

Label is not available on this site.

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
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
06/07/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20986lbl.pdf

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