Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021018
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMALOG MIX 50/50 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG MIX 50/50 KWIKPEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 UNITS/ML INJECTABLE;INJECTION Prescription None Yes Yes
HUMALOG MIX 50/50 PEN INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT 50 UNITS/ML;50 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/1999/21018lbl.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-129 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021018s127s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021018Orig1s127, s129ltr.pdf
11/15/2019 SUPPL-127 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021018s127s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021018Orig1s127, s129ltr.pdf
01/06/2017 SUPPL-111 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021018s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021018Orig1s111ltr.pdf
02/25/2015 SUPPL-100 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021018s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021018orig1s100ltr.pdf
09/12/2014 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

06/04/2014 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

04/11/2014 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

04/03/2014 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

03/18/2014 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

03/28/2013 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

01/30/2013 SUPPL-77 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s077ltr.pdf
09/26/2018 SUPPL-74 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021018Orig1s070s074ltr.pdf
09/26/2018 SUPPL-70 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021018Orig1s070s074ltr.pdf
10/30/2011 SUPPL-69 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021018s069lbl.pdf
03/11/2013 SUPPL-67 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021018Orig1s067ltr.pdf
03/21/2012 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

03/16/2009 SUPPL-49 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
08/22/2007 SUPPL-41 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
05/01/2008 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021018s035ltr.pdf
09/06/2007 SUPPL-34 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021018Orig1s034.pdf
09/07/2007 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018780s94187818819717682010031205636421017292101823r.pdf
11/19/2003 SUPPL-11 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21018scm011_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21018scm011ltr.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.

03/21/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-1 Labeling

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-129 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021018s127s129lbl.pdf
11/15/2019 SUPPL-127 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021018s127s129lbl.pdf
11/15/2019 SUPPL-127 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021018s127s129lbl.pdf
09/26/2018 SUPPL-74 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf
09/26/2018 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf
09/26/2018 SUPPL-70 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021018s070s074lbl.pdf
01/06/2017 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021018s111lbl.pdf
02/25/2015 SUPPL-100 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021018s100lbl.pdf
03/11/2013 SUPPL-67 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf
03/11/2013 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf
01/30/2013 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s077lbl.pdf
10/30/2011 SUPPL-69 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021018s069lbl.pdf
03/16/2009 SUPPL-49 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-34 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf
08/22/2007 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf
11/19/2003 SUPPL-11 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21018scm011_humalog_lbl.pdf
12/22/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21018lbl.pdf

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