Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021017
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMALOG MIX 75/25 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 75 UNITS/ML;25 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG MIX 75/25 KWIKPEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 75 UNITS/ML;25 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG MIX 75/25 PEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 75 UNITS/ML;25 UNITS/ML INJECTABLE;INJECTION Discontinued 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
12/22/1999 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21017_Humalog.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/15/2019 SUPPL-143 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021017s141s143lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021017Orig1s141, s143ltr.pdf
11/15/2019 SUPPL-141 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021017s141s143lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021017Orig1s141, s143ltr.pdf
01/06/2017 SUPPL-122 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021017s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021017Orig1s122ltr.pdf
04/24/2015 SUPPL-110 Manufacturing (CMC)

Label is not available on this site.

02/25/2015 SUPPL-108 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021017Orig1s108ltr.pdf
09/12/2014 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-102 Manufacturing (CMC)

Label is not available on this site.

04/11/2014 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

03/04/2014 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

05/10/2013 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-87 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-82 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s082ltr.pdf
09/26/2018 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021017Orig1s075,021017Orig1s079ltr.pdf
09/26/2018 SUPPL-75 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021017Orig1s075,021017Orig1s079ltr.pdf
10/30/2011 SUPPL-74 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021017s074lbl.pdf
03/11/2013 SUPPL-72 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021017Orig1s072ltr.pdf
03/21/2012 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

03/16/2009 SUPPL-53 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/2009/020563s091,021017s053,021018s049ltr.pdf
09/06/2007 SUPPL-40 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s075, 021017s040, 021018s034_ltr.pdf
08/22/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s065,021017s030,021018s041ltr.pdf
09/07/2007 SUPPL-29 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-25 Labeling

Label is not available on this site.

04/21/2004 SUPPL-18 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017scm018_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017scm018ltr.pdf
04/23/2004 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf
11/19/2003 SUPPL-13 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21017scm013_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017scm013ltr.pdf
06/30/2003 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21017slr010ltr.pdf
04/23/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21017slr006,015ltr.pdf
10/25/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-2 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021017_S002_Humalog Mix_APPROVAL PACKAGE.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/15/2019 SUPPL-143 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021017s141s143lbl.pdf
11/15/2019 SUPPL-141 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021017s141s143lbl.pdf
11/15/2019 SUPPL-141 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021017s141s143lbl.pdf
09/26/2018 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf
09/26/2018 SUPPL-75 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021017s075s079lbl.pdf
01/06/2017 SUPPL-122 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021017s122lbl.pdf
02/25/2015 SUPPL-108 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021017s108lbl.pdf
03/11/2013 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s072lbl.pdf
03/11/2013 SUPPL-72 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s072lbl.pdf
01/30/2013 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021017s082lbl.pdf
10/30/2011 SUPPL-74 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021017s074lbl.pdf
03/16/2009 SUPPL-53 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
09/06/2007 SUPPL-40 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf
08/22/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf
04/23/2004 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf
04/23/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017slr006,015_humalog_lbl.pdf
04/21/2004 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21017scm018_humalog_lbl.pdf
11/19/2003 SUPPL-13 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21017scm013_humalog_lbl.pdf
12/22/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21017lbl.pdf

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