Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021017
Company: LILLY
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 | No | No |
| HUMALOG MIX 75/25 KWIKPEN | INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT | 75 UNITS/ML;25 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| 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 | N/A |
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 |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-146 | 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-143 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-108 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-102 | Supplement |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-100 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-99 | Supplement |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-98 | Supplement |
Label is not available on this site. |
||
| 03/04/2014 | SUPPL-97 | Supplement |
Label is not available on this site. |
||
| 12/12/2013 | SUPPL-95 | Supplement |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-94 | Supplement |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-91 | Supplement |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-88 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-87 | Supplement |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-86 | Supplement |
Label is not available on this site. |
||
| 01/30/2013 | SUPPL-82 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021017s074lbl.pdf | |
| 03/11/2013 | SUPPL-72 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 03/16/2009 | SUPPL-53 | 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 | |
| 09/06/2007 | SUPPL-40 | Supplement |
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 | 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 | |
| 09/07/2007 | SUPPL-29 | 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-25 | Supplement |
Label is not available on this site. |
||
| 04/21/2004 | SUPPL-18 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 04/05/2002 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-2 | Supplement |
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 |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-146 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 07/21/2023 | SUPPL-146 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 07/21/2023 | SUPPL-146 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020563s202,021017s146,021018s132,205747s028lbl.pdf | |
| 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 |