Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021018
Company: LILLY
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 | No | No |
| HUMALOG MIX 50/50 KWIKPEN | INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT | 50 UNITS/ML;50 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| 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 | N/A |
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 |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-132 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020563Orig1s202,021017Orig1s146,021018Orig1s132,205747Orig1s028ltr.pdf | |
| 11/15/2019 | SUPPL-129 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-95 | Supplement |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-93 | Supplement |
Label is not available on this site. |
||
| 04/03/2014 | SUPPL-92 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-91 | Supplement |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-90 | Supplement |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-88 | Supplement |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-85 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-81 | Supplement |
Label is not available on this site. |
||
| 01/30/2013 | SUPPL-77 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021018s069lbl.pdf | |
| 03/11/2013 | SUPPL-67 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-49 | 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/2009/020563s091,021017s053,021018s049ltr.pdf | |
| 08/22/2007 | SUPPL-41 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 04/05/2002 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 03/21/2002 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 02/08/2002 | 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 |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-132 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 07/21/2023 | SUPPL-132 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 07/21/2023 | SUPPL-132 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 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-Container/Carton Labels | 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 | |
| 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-74 | Labeling-Patient 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s067lbl.pdf | |
| 03/11/2013 | SUPPL-67 | Labeling-Patient 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 |