Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019717
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 Yes Yes
HUMULIN 70/30 PEN INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 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
04/25/1989 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
11/15/2019 SUPPL-169 Labeling-Package Insert 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling-Container/Carton Labels, Labeling-Patient Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-126 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-124 Labeling-Container/Carton Labels 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 Labeling-Container/Carton Labels 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 Manufacturing (CMC)

Label is not available on this site.

04/03/2014 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-120 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-119 Manufacturing (CMC)

Label is not available on this site.

03/04/2014 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

05/31/2013 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

05/30/2013 SUPPL-112 Manufacturing (CMC)

Label is not available on this site.

08/21/2013 SUPPL-111 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-108 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

11/07/2013 SUPPL-101 Labeling-Package Insert 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 Labeling-Package Insert, Labeling-Patient Package Insert 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 Labeling-Container/Carton Labels 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 Labeling-Patient Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

03/16/2009 SUPPL-87 Manufacturing (CMC)-Control 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 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-68 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-65 Labeling

Label is not available on this site.

11/10/2004 SUPPL-60 Labeling 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 Labeling 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 Manufacturing (CMC) 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 Labeling 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 Labeling 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 Manufacturing (CMC)

Label is not available on this site.

08/29/2002 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/2002 SUPPL-41 Labeling 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 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2002 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2002 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/2002 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/2002 SUPPL-35 Manufacturing (CMC)-Control 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 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
11/01/2002 SUPPL-30 Labeling 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 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1998 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1997 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1997 SUPPL-23 Labeling

Label is not available on this site.

01/28/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/10/1996 SUPPL-20 Labeling

Label is not available on this site.

07/26/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

11/09/1995 SUPPL-14 Labeling

Label is not available on this site.

09/29/1995 SUPPL-13 Labeling

Label is not available on this site.

03/09/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1995 SUPPL-11 Labeling

Label is not available on this site.

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

Label is not available on this site.

12/07/1992 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/23/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1992 SUPPL-7 Labeling

Label is not available on this site.

01/11/1994 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/1991 SUPPL-5 Labeling

Label is not available on this site.

09/24/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1990 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1990 SUPPL-2 Labeling

Label is not available on this site.

05/26/1989 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
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-Container/Carton Labels 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
08/22/2019 SUPPL-165 Labeling-Container/Carton Labels 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-Patient Package Insert 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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf
02/25/2015 SUPPL-133 Labeling-Patient Package Insert 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 Yes 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 Yes 019717 LILLY
NOVOLIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 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 Yes 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 Yes 019717 LILLY
NOVOLIN 70/30 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN 30 UNITS/ML;70 UNITS/ML INJECTABLE;INJECTION Over-the-counter Yes 019991 NOVO NORDISK INC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English