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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 018780
Company: LILLY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMULIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter None No No
HUMULIN R INSULIN HUMAN 10000 UNITS/20ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R KWIKPEN INSULIN HUMAN 1500 UNITS/3ML (500 UNITS/ML) SOLUTION;SUBCUTANEOUS Prescription None No No
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter 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
10/28/1982 ORIG-1 Approval N/A

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/27/2022 SUPPL-180 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018780Orig1s180ltr.pdf
11/15/2019 SUPPL-176 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s175, s176ltr.pdf
11/15/2019 SUPPL-175 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s175, s176ltr.pdf
08/22/2019 SUPPL-172 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018780Orig1s172ltr.pdf
11/06/2018 SUPPL-168 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s168ltr.pdf
06/24/2016 SUPPL-155 Supplement

Label is not available on this site.
02/26/2016 SUPPL-154 Supplement

Label is not available on this site.
07/08/2016 SUPPL-153 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018780Orig1s153ltr.pdf
12/29/2015 SUPPL-152 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf
10/08/2015 SUPPL-151 Supplement

Label is not available on this site.
02/25/2015 SUPPL-150 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s150ltr.pdf
10/30/2014 SUPPL-149 Supplement

Label is not available on this site.
09/23/2014 SUPPL-148 Supplement Label (PDF)
Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf
06/20/2014 SUPPL-147 Supplement

Label is not available on this site.
03/18/2014 SUPPL-146 Supplement

Label is not available on this site.
08/15/2013 SUPPL-145 Supplement

Label is not available on this site.
05/31/2013 SUPPL-144 Supplement

Label is not available on this site.
05/30/2013 SUPPL-143 Supplement

Label is not available on this site.
05/10/2013 SUPPL-142 Supplement

Label is not available on this site.
11/07/2012 SUPPL-141 Supplement

Label is not available on this site.
01/09/2013 SUPPL-139 Supplement

Label is not available on this site.
12/29/2015 SUPPL-135 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018780Orig1s135s152ltr.pdf
05/25/2018 SUPPL-134 Supplement Letter (PDF)
Label for HUMULIN R U-100

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s126,s134ltr.pdf
10/30/2011 SUPPL-133 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s133ltr.pdf
03/09/2013 SUPPL-132 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018780Orig1s132ltr.pdf
06/10/2010 SUPPL-128 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf
03/29/2012 SUPPL-127 Supplement

Label is not available on this site.
05/25/2018 SUPPL-126 Supplement Label (PDF)
Letter (PDF)
Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s126s134lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018780Orig1s126,s134ltr.pdf
03/21/2011 SUPPL-124 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s124ltr.pdf
03/25/2011 SUPPL-120 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018780s120ltr.pdf
09/10/2007 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s114ltr.pdf
08/22/2007 SUPPL-95 Supplement 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-94 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf
02/25/2005 SUPPL-86 Supplement 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
11/10/2003 SUPPL-80 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm080ltr.pdf
02/10/2003 SUPPL-78 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf
10/25/2002 SUPPL-76 Supplement

Label is not available on this site.
08/29/2002 SUPPL-75 Supplement

Label is not available on this site.
08/29/2002 SUPPL-74 Supplement

Label is not available on this site.
08/29/2002 SUPPL-73 Supplement

Label is not available on this site.
08/21/2002 SUPPL-72 Supplement

Label is not available on this site.
08/21/2002 SUPPL-71 Supplement

Label is not available on this site.
10/10/2002 SUPPL-70 Supplement

Label is not available on this site.
03/13/2002 SUPPL-69 Supplement

Label is not available on this site.
02/10/2003 SUPPL-67 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf
04/14/2003 SUPPL-66 Supplement Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780slr066ltr.pdf
08/29/2002 SUPPL-65 Supplement

Label is not available on this site.
04/19/2000 SUPPL-64 Supplement

Label is not available on this site.
11/02/1999 SUPPL-63 Supplement

Label is not available on this site.
02/25/1999 SUPPL-61 Supplement

Label is not available on this site.
08/06/1998 SUPPL-58 Supplement

Label is not available on this site.
02/20/1998 SUPPL-57 Supplement

Label is not available on this site.
04/16/1997 SUPPL-56 Supplement

Label is not available on this site.
04/16/1997 SUPPL-55 Supplement

Label is not available on this site.
01/28/1997 SUPPL-54 Supplement

Label is not available on this site.
07/26/1996 SUPPL-52 Supplement

Label is not available on this site.
07/10/1996 SUPPL-51 Supplement

Label is not available on this site.
07/26/1996 SUPPL-50 Supplement

Label is not available on this site.
04/25/1996 SUPPL-49 Supplement

Label is not available on this site.
02/15/1996 SUPPL-48 Supplement

Label is not available on this site.
02/14/1996 SUPPL-47 Supplement

Label is not available on this site.
11/09/1995 SUPPL-46 Supplement

Label is not available on this site.
09/29/1995 SUPPL-45 Supplement

Label is not available on this site.
03/09/1995 SUPPL-44 Supplement

Label is not available on this site.
02/22/1995 SUPPL-43 Supplement

Label is not available on this site.
03/31/1994 SUPPL-42 Supplement

Label is not available on this site.
12/07/1992 SUPPL-41 Supplement

Label is not available on this site.
05/10/1993 SUPPL-40 Supplement

Label is not available on this site.
06/14/1994 SUPPL-39 Supplement

Label is not available on this site.
01/27/1992 SUPPL-38 Supplement

Label is not available on this site.
01/11/1994 SUPPL-37 Supplement Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018780_s037.pdf
03/12/1991 SUPPL-36 Supplement

Label is not available on this site.
11/15/1991 SUPPL-35 Supplement

Label is not available on this site.
09/24/1990 SUPPL-34 Supplement

Label is not available on this site.
08/17/1990 SUPPL-33 Supplement

Label is not available on this site.
01/23/1989 SUPPL-32 Supplement

Label is not available on this site.
07/29/1988 SUPPL-31 Supplement

Label is not available on this site.
02/01/1989 SUPPL-30 Supplement

Label is not available on this site.
03/24/1988 SUPPL-29 Supplement

Label is not available on this site.
10/27/1987 SUPPL-28 Supplement

Label is not available on this site.
06/10/1988 SUPPL-27 Supplement

Label is not available on this site.
07/10/1987 SUPPL-26 Supplement

Label is not available on this site.
05/28/1986 SUPPL-24 Supplement

Label is not available on this site.
07/13/1987 SUPPL-23 Supplement

Label is not available on this site.
05/07/1987 SUPPL-22 Supplement

Label is not available on this site.
07/28/1987 SUPPL-21 Supplement

Label is not available on this site.
09/15/1986 SUPPL-20 Supplement

Label is not available on this site.
04/10/1986 SUPPL-18 Supplement

Label is not available on this site.
03/08/1985 SUPPL-16 Supplement

Label is not available on this site.
11/23/1984 SUPPL-14 Supplement

Label is not available on this site.
12/26/1984 SUPPL-13 Supplement

Label is not available on this site.
02/28/1984 SUPPL-12 Supplement

Label is not available on this site.
01/26/1984 SUPPL-11 Supplement

Label is not available on this site.
07/25/1984 SUPPL-9 Supplement

Label is not available on this site.
10/12/1983 SUPPL-8 Supplement

Label is not available on this site.
08/24/1983 SUPPL-7 Supplement

Label is not available on this site.
03/14/1983 SUPPL-5 Supplement

Label is not available on this site.
01/27/1983 SUPPL-4 Supplement

Label is not available on this site.
01/31/1983 SUPPL-3 Supplement

Label is not available on this site.
12/02/1982 SUPPL-2 Supplement

Label is not available on this site.
12/02/1982 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
06/27/2022 SUPPL-180 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
06/27/2022 SUPPL-180 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
06/27/2022 SUPPL-180 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018780s180lbl.pdf
11/15/2019 SUPPL-176 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
11/15/2019 SUPPL-175 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
11/15/2019 SUPPL-175 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s175s176lbl.pdf
08/22/2019 SUPPL-172 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
08/22/2019 SUPPL-172 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
08/22/2019 SUPPL-172 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018780s172lbl.pdf
11/06/2018 SUPPL-168 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 and U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s168lbl.pdf
05/25/2018 SUPPL-126 Manufacturing (CMC) Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018780s126s134lbl.pdf
07/08/2016 SUPPL-153 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf
07/08/2016 SUPPL-153 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf
12/29/2015 SUPPL-152 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-152 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-152 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
12/29/2015 SUPPL-135 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-500 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf
02/25/2015 SUPPL-150 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf
02/25/2015 SUPPL-150 Labeling-Container/Carton Labels Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s150lbl.pdf
09/23/2014 SUPPL-148 Manufacturing (CMC) Label (PDF) Label for HUMULIN R U-500 This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018780s148lbl.pdf
03/09/2013 SUPPL-132 Labeling-Patient Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf
03/09/2013 SUPPL-132 Labeling-Package Insert Label (PDF) Label for HUMULIN R U-100 https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018780s132lbl.pdf
03/25/2011 SUPPL-120 Efficacy-New Route Of Administration Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf
06/10/2010 SUPPL-128 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018780s128lbl.pdf
09/10/2007 SUPPL-114 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s114lbl.pdf
08/22/2007 SUPPL-95 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf
02/25/2005 SUPPL-86 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
11/10/2003 SUPPL-80 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf
02/10/2003 SUPPL-78 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018780s078lbl.pdf
02/10/2003 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18780scm078,slr067ltr.pdf

HUMULIN 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 No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC

HUMULIN 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 No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC

HUMULIN R KWIKPEN

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

HUMULIN R PEN

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 No 018780 LILLY
HUMULIN R PEN INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 018780 LILLY
NOVOLIN R INSULIN RECOMBINANT HUMAN 100 UNITS/ML INJECTABLE;INJECTION Over-the-counter No 019938 NOVO NORDISK INC
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