Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019938
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/1991 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/01/2018 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019938s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019938Orig1s076ltr.pdf
11/18/2016 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

01/08/2016 SUPPL-74 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019938Orig1s074ltr.pdf
12/01/2015 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

02/07/2013 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s072ltr.pdf
03/09/2013 SUPPL-71 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019938Orig1s071ltr.pdf
06/25/2010 SUPPL-69 Labeling-Container/Carton Labels 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
12/27/2010 SUPPL-68 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019938s068_019959s070_019991s071ltr.pdf
06/25/2010 SUPPL-67 Labeling-Container/Carton Labels 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
02/27/2012 SUPPL-66 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019938s066ltr.pdf
07/17/2009 SUPPL-64 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter
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.pd
06/15/2009 SUPPL-63 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019938s063,019959s066,019991s067ltr.pdf
10/21/2005 SUPPL-48 Efficacy-New Route Of Administration Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf
11/18/2005 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019938s037ltr.pdf
06/19/2002 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/10/2002 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/2001 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/2002 SUPPL-33 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s33ltr.pdf
04/11/2002 SUPPL-32 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19959s34ltr.pdf
01/09/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/2002 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19938s30ltr.pdf
12/10/2001 SUPPL-29 Labeling

Label is not available on this site.

06/15/2000 SUPPL-27 Labeling

Label is not available on this site.

04/10/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/18/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/24/1998 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1997 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/1997 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1997 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938ap.pdf
04/10/1997 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019938a_s019.pdf
06/13/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/28/1997 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1995 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1994 SUPPL-14 Labeling

Label is not available on this site.

01/03/1994 SUPPL-13 Labeling

Label is not available on this site.

06/23/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/23/1994 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1994 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1994 SUPPL-6 Labeling

Label is not available on this site.

03/26/1993 SUPPL-5 Labeling

Label is not available on this site.

03/26/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1991 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/01/2018 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019938s076lbl.pdf
01/08/2016 SUPPL-74 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019938s074lbl.pdf
03/09/2013 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf
03/09/2013 SUPPL-71 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s071lbl.pdf
02/07/2013 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019938s072lbl.pdf
02/27/2012 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019938s066lbl.pdf
07/17/2009 SUPPL-64 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
07/17/2009 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf
06/15/2009 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf
11/18/2005 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf
10/21/2005 SUPPL-48 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s048lbl.pdf
04/15/2002 SUPPL-33 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf
04/11/2002 SUPPL-32 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf
03/11/2002 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf

NOVOLIN R

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

INJECTABLE;INJECTION; 100 UNITS/ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
HUMULIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 019938 NOVO NORDISK INC

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