Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018781
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN N INSULIN SUSP ISOPHANE 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
10/28/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
11/15/2019 SUPPL-188 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018781s187s188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018781Orig1s187, s188ltr.pdf
11/15/2019 SUPPL-187 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018781s187s188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018781Orig1s187, s188ltr.pdf
08/22/2019 SUPPL-184 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18781s184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018781Orig1s184ltr.pdf
11/06/2018 SUPPL-181 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018781s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018781Orig1s181ltr.pdf
01/06/2017 SUPPL-167 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018781s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018781Orig1s167ltr.pdf
04/05/2016 SUPPL-163 Manufacturing (CMC)

Label is not available on this site.

04/22/2016 SUPPL-161 Manufacturing (CMC)

Label is not available on this site.

02/19/2016 SUPPL-160 Manufacturing (CMC)

Label is not available on this site.

10/20/2015 SUPPL-159 Manufacturing (CMC)

Label is not available on this site.

10/08/2015 SUPPL-158 Manufacturing (CMC)

Label is not available on this site.

07/15/2015 SUPPL-157 Manufacturing (CMC)

Label is not available on this site.

03/12/2015 SUPPL-156 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s156ltr.pdf
03/03/2015 SUPPL-155 Manufacturing (CMC)

Label is not available on this site.

02/25/2015 SUPPL-154 Labeling-Container/Carton Labels, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018781Orig1s154ltr.pdf
01/12/2015 SUPPL-153 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-150 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-147 Manufacturing (CMC)

Label is not available on this site.

06/10/2014 SUPPL-146 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-145 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018781Orig1s145ltr.pdf
12/09/2013 SUPPL-144 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s144ltr.pdf
04/11/2014 SUPPL-143 Manufacturing (CMC)

Label is not available on this site.

04/03/2014 SUPPL-142 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-141 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-140 Manufacturing (CMC)

Label is not available on this site.

03/04/2014 SUPPL-139 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-137 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

05/31/2013 SUPPL-134 Manufacturing (CMC)

Label is not available on this site.

05/30/2013 SUPPL-133 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-132 Manufacturing (CMC)

Label is not available on this site.

02/21/2013 SUPPL-131 Manufacturing (CMC)

Label is not available on this site.

03/25/2013 SUPPL-130 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-129 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-128 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-126 Manufacturing (CMC)

Label is not available on this site.

12/03/2012 SUPPL-125 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-122 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf
03/09/2013 SUPPL-121 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s121ltr.pdf
09/30/2014 SUPPL-120 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf
11/07/2013 SUPPL-118 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018781Orig1s118,s122ltr.pdf
06/10/2010 SUPPL-114 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf
03/21/2012 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

03/16/2009 SUPPL-108 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf
08/22/2007 SUPPL-89 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s095,018781s089,019717s069,020100s032ltr.pdf
09/07/2007 SUPPL-88 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf
11/09/2005 SUPPL-85 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018781s025,060,065,085ltr.pdf
02/25/2005 SUPPL-80 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18780s086,18781s080ltr.pdf
09/03/2004 SUPPL-79 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781s079ltr.pdf
04/21/2004 SUPPL-76 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781slr076ltr.pdf
11/19/2003 SUPPL-74 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781scm074ltr.pdf
06/22/2003 SUPPL-72 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781slr072_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr072ltr.pdf
11/20/2003 SUPPL-70 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf
08/29/2002 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2002 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2003 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18781slr060,070ltr.pdf
02/12/2003 SUPPL-57 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr027,19717slr032,18781slr057ltr.pdf
07/07/2000 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/2002 SUPPL-54 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18781slr054ltr.pdf
02/25/1999 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1998 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/24/1997 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/1998 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1997 SUPPL-47 Labeling

Label is not available on this site.

01/28/1997 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

07/10/1996 SUPPL-44 Labeling

Label is not available on this site.

07/26/1996 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1996 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1996 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/15/1996 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-38 Labeling

Label is not available on this site.

09/29/1995 SUPPL-37 Labeling

Label is not available on this site.

03/09/1995 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-35 Labeling

Label is not available on this site.

02/10/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/27/1995 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/07/1992 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/11/1994 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1991 SUPPL-30 Labeling

Label is not available on this site.

09/24/1990 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1990 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/03/1991 SUPPL-27 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018781_s027_Humulin N.pdf
01/23/1989 SUPPL-26 Labeling

Label is not available on this site.

07/29/1988 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1988 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1988 SUPPL-23 Labeling

Label is not available on this site.

10/27/1987 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/27/1987 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/10/1987 SUPPL-19 Labeling

Label is not available on this site.

07/13/1987 SUPPL-18 Labeling

Label is not available on this site.

07/13/1987 SUPPL-17 Labeling

Label is not available on this site.

07/28/1987 SUPPL-16 Labeling

Label is not available on this site.

10/27/1987 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/31/1987 SUPPL-14 Labeling

Label is not available on this site.

06/28/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/26/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/29/1984 SUPPL-8 Labeling

Label is not available on this site.

07/25/1984 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/12/1983 SUPPL-6 Labeling

Label is not available on this site.

08/24/1983 SUPPL-5 Labeling

Label is not available on this site.

01/27/1983 SUPPL-4 Labeling

Label is not available on this site.

01/31/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1982 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/02/1982 SUPPL-1 Labeling

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-188 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018781s187s188lbl.pdf
11/15/2019 SUPPL-187 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018781s187s188lbl.pdf
11/15/2019 SUPPL-187 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018781s187s188lbl.pdf
08/22/2019 SUPPL-184 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18781s184lbl.pdf
08/22/2019 SUPPL-184 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18781s184lbl.pdf
08/22/2019 SUPPL-184 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18781s184lbl.pdf
11/06/2018 SUPPL-181 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018781s181lbl.pdf
01/06/2017 SUPPL-167 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018781s167lbl.pdf
03/12/2015 SUPPL-156 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s156lbl.pdf
02/25/2015 SUPPL-154 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf
02/25/2015 SUPPL-154 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf
09/30/2014 SUPPL-120 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf
11/07/2013 SUPPL-122 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf
11/07/2013 SUPPL-118 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf
03/09/2013 SUPPL-121 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf
06/10/2010 SUPPL-114 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf
03/16/2009 SUPPL-108 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018781s108,020563s091,021017s053,021018s049lbl.pdf
08/22/2007 SUPPL-89 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf
11/09/2005 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf
02/25/2005 SUPPL-80 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf
09/03/2004 SUPPL-79 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf
04/21/2004 SUPPL-76 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf
11/19/2003 SUPPL-74 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf
06/22/2003 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781slr072_humulin_lbl.pdf
02/12/2003 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf

HUMULIN N

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 N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 018781 LILLY
NOVOLIN N INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 019959 NOVO NORDISK INC

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