Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019717
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HUMULIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | None | No | No |
| HUMULIN 70/30 PEN | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 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 |
|---|---|---|---|---|---|---|---|
| 04/25/1989 | 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-174 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019717s174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019717Orig1s174ltr.pdf | |
| 11/15/2019 | SUPPL-169 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s168s169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019717Orig1s168, s169ltr.pdf | |
| 11/15/2019 | SUPPL-168 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s168s169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019717Orig1s168, s169ltr.pdf | |
| 08/22/2019 | SUPPL-165 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019717Orig1s165ltr.pdf | |
| 11/06/2018 | SUPPL-161 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019717s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019717Orig1s161ltr.pdf | |
| 01/06/2017 | SUPPL-146 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019717s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019717Orig1s146ltr.pdf | |
| 03/12/2015 | SUPPL-135 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s135ltr.pdf | |
| 02/25/2015 | SUPPL-133 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019717Orig1s133ltr.pdf | |
| 09/12/2014 | SUPPL-129 | Supplement |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-126 | Supplement |
Label is not available on this site. |
||
| 01/15/2014 | SUPPL-124 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019717Orig1s124ltr.pdf |
| 12/09/2013 | SUPPL-123 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s123ltr.pdf |
| 04/11/2014 | SUPPL-122 | Supplement |
Label is not available on this site. |
||
| 04/03/2014 | SUPPL-121 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-120 | Supplement |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-119 | Supplement |
Label is not available on this site. |
||
| 03/04/2014 | SUPPL-118 | Supplement |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-116 | Supplement |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-115 | Supplement |
Label is not available on this site. |
||
| 05/31/2013 | SUPPL-113 | Supplement |
Label is not available on this site. |
||
| 05/30/2013 | SUPPL-112 | Supplement |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-111 | Supplement |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-108 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-107 | Supplement |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-105 | Supplement |
Label is not available on this site. |
||
| 11/07/2013 | SUPPL-101 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf | |
| 03/09/2013 | SUPPL-99 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s099ltr.pdf | |
| 11/07/2013 | SUPPL-98 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019717Orig1s098,s101ltr.pdf | |
| 06/10/2010 | SUPPL-94 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019717s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018780s128,018781s114,019717s094ltr.pdf | |
| 03/21/2012 | SUPPL-93 | Supplement |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-87 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021018s049,018781s108,019717s087ltr.pdf |
| 08/22/2007 | SUPPL-69 | 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-68 | 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-65 | Supplement |
Label is not available on this site. |
||
| 11/10/2004 | SUPPL-60 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717s060ltr.pdf | |
| 04/23/2004 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717slr058_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19717slr058ltr.pdf | |
| 11/19/2003 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717scm054_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717scm054ltr.pdf | |
| 06/22/2003 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr052_humulin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr052ltr.pdf | |
| 11/17/2003 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr050_humilin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19717slr050ltr.pdf | |
| 09/25/2002 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 08/29/2002 | SUPPL-45 | Supplement |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-44 | Supplement |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
| 10/03/2002 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19717s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr041ltr.pdf | |
| 03/29/2002 | SUPPL-40 | Supplement |
Label is not available on this site. |
||
| 03/22/2002 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
| 03/14/2002 | SUPPL-38 | Supplement |
Label is not available on this site. |
||
| 02/28/2002 | SUPPL-37 | Supplement |
Label is not available on this site. |
||
| 04/02/2002 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-35 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19-717S035.pdf |
| 02/12/2003 | SUPPL-32 | Supplement |
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 | |
| 11/01/2002 | SUPPL-30 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19717slr030ltr.pdf |
| 02/25/1999 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 08/06/1998 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
| 07/10/1996 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 07/26/1996 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 01/26/1996 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 02/15/1996 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 11/09/1995 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 09/29/1995 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 03/09/1995 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 02/10/1995 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 12/07/1992 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 02/23/1994 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 01/27/1992 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 01/11/1994 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 09/24/1990 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 04/22/1990 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 05/23/1990 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 05/26/1989 | 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-174 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019717s174lbl.pdf | |
| 06/27/2022 | SUPPL-174 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019717s174lbl.pdf | |
| 06/27/2022 | SUPPL-174 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019717s174lbl.pdf | |
| 11/15/2019 | SUPPL-169 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s168s169lbl.pdf | |
| 11/15/2019 | SUPPL-168 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s168s169lbl.pdf | |
| 11/15/2019 | SUPPL-168 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s168s169lbl.pdf | |
| 08/22/2019 | SUPPL-165 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s165lbl.pdf | |
| 08/22/2019 | SUPPL-165 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s165lbl.pdf | |
| 08/22/2019 | SUPPL-165 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019717s165lbl.pdf | |
| 11/06/2018 | SUPPL-161 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019717s161lbl.pdf | |
| 01/06/2017 | SUPPL-146 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019717s146lbl.pdf | |
| 03/12/2015 | SUPPL-135 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s135lbl.pdf | |
| 02/25/2015 | SUPPL-133 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf | |
| 02/25/2015 | SUPPL-133 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf | |
| 11/07/2013 | SUPPL-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf | |
| 11/07/2013 | SUPPL-98 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf | |
| 03/09/2013 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf | |
| 03/09/2013 | SUPPL-99 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf | |
| 06/10/2010 | SUPPL-94 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019717s094lbl.pdf | |
| 08/22/2007 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf | |
| 11/10/2004 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717s060lbl.pdf | |
| 04/23/2004 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717slr058_humulin_lbl.pdf | |
| 11/19/2003 | SUPPL-54 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717scm054_humulin_lbl.pdf |
| 11/17/2003 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr050_humilin_lbl.pdf | |
| 06/22/2003 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr052_humulin_lbl.pdf | |
| 02/12/2003 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf | |
| 10/03/2002 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19717s41lbl.pdf |
HUMULIN 70/30
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
INJECTABLE;INJECTION; 30 UNITS/ML;70 UNITS/ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HUMULIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019717 | LILLY |
| HUMULIN 70/30 PEN | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019717 | LILLY |
| NOVOLIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019991 | NOVO NORDISK INC |
HUMULIN 70/30 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; 30 UNITS/ML;70 UNITS/ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| HUMULIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019717 | LILLY |
| HUMULIN 70/30 PEN | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019717 | LILLY |
| NOVOLIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | 30 UNITS/ML;70 UNITS/ML | INJECTABLE;INJECTION | Over-the-counter | No | 019991 | NOVO NORDISK INC |