Drugs@FDA: FDA-Approved Drugs
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 | 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-193 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018781s193lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018781Orig1s193ltr.pdf | |
| 11/15/2019 | SUPPL-188 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 04/22/2016 | SUPPL-161 | Supplement |
Label is not available on this site. |
||
| 02/19/2016 | SUPPL-160 | Supplement |
Label is not available on this site. |
||
| 10/20/2015 | SUPPL-159 | Supplement |
Label is not available on this site. |
||
| 10/08/2015 | SUPPL-158 | Supplement |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-157 | Supplement |
Label is not available on this site. |
||
| 03/12/2015 | SUPPL-156 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-154 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-150 | Supplement |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-147 | Supplement |
Label is not available on this site. |
||
| 06/10/2014 | SUPPL-146 | Supplement |
Label is not available on this site. |
||
| 01/15/2014 | SUPPL-145 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 04/03/2014 | SUPPL-142 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-141 | Supplement |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-140 | Supplement |
Label is not available on this site. |
||
| 03/04/2014 | SUPPL-139 | Supplement |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-137 | Supplement |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-136 | Supplement |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-134 | Supplement |
Label is not available on this site. |
||
| 05/30/2013 | SUPPL-133 | Supplement |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-132 | Supplement |
Label is not available on this site. |
||
| 02/21/2013 | SUPPL-131 | Supplement |
Label is not available on this site. |
||
| 03/25/2013 | SUPPL-130 | Supplement |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-129 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-128 | Supplement |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-126 | Supplement |
Label is not available on this site. |
||
| 12/03/2012 | SUPPL-125 | Supplement |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-122 | Supplement |
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 | Supplement |
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 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018781s120lbl.pdf | |
| 11/07/2013 | SUPPL-118 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-108 | Supplement |
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 | 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-88 | Supplement |
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 | Supplement |
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 | 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 | |
| 09/03/2004 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18781slr076ltr.pdf | |
| 04/21/2004 | SUPPL-76 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-66 | Supplement |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-64 | Supplement |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-63 | Supplement |
Label is not available on this site. |
||
| 10/31/2002 | SUPPL-62 | Supplement |
Label is not available on this site. |
||
| 04/02/2002 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
| 11/20/2003 | SUPPL-60 | Supplement |
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 | Supplement |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
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 | Supplement |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-55 | Supplement |
Label is not available on this site. |
||
| 11/05/2002 | SUPPL-54 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 06/24/1997 | SUPPL-49 | Supplement |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 07/10/1996 | SUPPL-44 | Supplement |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-41 | Supplement |
Label is not available on this site. |
||
| 01/26/1996 | SUPPL-40 | Supplement |
Label is not available on this site. |
||
| 02/15/1996 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-38 | Supplement |
Label is not available on this site. |
||
| 09/29/1995 | SUPPL-37 | Supplement |
Label is not available on this site. |
||
| 03/09/1995 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 02/10/1995 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
| 12/07/1992 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
| 01/11/1994 | SUPPL-31 | Supplement |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 09/24/1990 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 08/17/1990 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-27 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 07/29/1988 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 03/03/1988 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 03/24/1988 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 07/10/1987 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 07/13/1987 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 07/13/1987 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 07/28/1987 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 07/31/1987 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 06/28/1988 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 12/26/1984 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 02/14/1985 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 02/29/1984 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/25/1984 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 08/24/1983 | 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-193 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018781s193lbl.pdf | |
| 06/27/2022 | SUPPL-193 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018781s193lbl.pdf | |
| 06/27/2022 | SUPPL-193 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018781s193lbl.pdf | |
| 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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/18781s184lbl.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-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 |
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 | No | 018781 | LILLY |
| NOVOLIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 100 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019959 | NOVO NORDISK INC |