Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020563
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HUMALOG | INSULIN LISPRO RECOMBINANT | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMALOG KWIKPEN | INSULIN LISPRO RECOMBINANT | 100 UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMALOG KWIKPEN | INSULIN LISPRO RECOMBINANT | 200UNITS/ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMALOG PEN | INSULIN LISPRO RECOMBINANT | 100 UNITS/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HUMALOG TEMPO PEN | INSULIN LISPRO RECOMBINANT | 100UNITS/ML | INJECTABLE;INJECTION | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 06/14/1996 | ORIG-1 | Approval | N/A |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020563Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-202 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020563Orig1s202,021017Orig1s146,021018Orig1s132,205747Orig1s028ltr.pdf | |
| 11/15/2019 | SUPPL-199 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf | |
| 11/15/2019 | SUPPL-198 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf | |
| 11/15/2019 | SUPPL-196 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s196, s198, s199; 205747Orig1s022, 025, 026ltr.pdf | |
| 08/13/2019 | SUPPL-195 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020563Orig1s195, 205747Orig1s021ltr.pdf | |
| 11/01/2018 | SUPPL-191 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020563orig1s191,205747Orig1s018ltr.pdf | |
| 12/11/2018 | SUPPL-190 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020563Orig1s190ltr.pdf | |
| 06/06/2017 | SUPPL-176 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s176ltr.pdf | |
| 01/06/2017 | SUPPL-172 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf | |
| 06/12/2015 | SUPPL-163 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s163ltr.pdf | |
| 09/10/2015 | SUPPL-161 | Supplement |
Label is not available on this site. |
||
| 06/11/2015 | SUPPL-159 | Supplement |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-157 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s157ltr.pdf | |
| 01/26/2015 | SUPPL-156 | Supplement |
Label is not available on this site. |
||
| 11/11/2014 | SUPPL-155 | Supplement |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-152 | Supplement |
Label is not available on this site. |
||
| 06/04/2014 | SUPPL-150 | Supplement |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-149 | Supplement |
Label is not available on this site. |
||
| 04/03/2014 | SUPPL-148 | Supplement |
Label is not available on this site. |
||
| 04/01/2014 | SUPPL-147 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-146 | Supplement |
Label is not available on this site. |
||
| 03/18/2014 | SUPPL-145 | Supplement |
Label is not available on this site. |
||
| 03/04/2014 | SUPPL-144 | Supplement |
Label is not available on this site. |
||
| 01/31/2014 | SUPPL-143 | Supplement |
Label is not available on this site. |
||
| 08/15/2013 | SUPPL-142 | Supplement |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-141 | Supplement |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-139 | Supplement |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-137 | Supplement |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-135 | Supplement |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-134 | Supplement |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-133 | Supplement |
Label is not available on this site. |
||
| 02/15/2013 | SUPPL-132 | Supplement |
Label is not available on this site. |
||
| 06/12/2013 | SUPPL-131 | Supplement |
Label is not available on this site. |
||
| 01/30/2013 | SUPPL-127 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s127ltr.pdf | |
| 03/13/2015 | SUPPL-124 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020563Orig1s124ltr.pdf | |
| 10/14/2012 | SUPPL-123 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020563Orig1s123ltr.pdf | |
| 10/30/2011 | SUPPL-117 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf | |
| 03/11/2013 | SUPPL-115 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020563Orig1s115ltr.pdf | |
| 05/18/2011 | SUPPL-105 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf | |
| 05/18/2011 | SUPPL-98 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020563s105,s098ltr.pdf | |
| 03/16/2009 | SUPPL-91 | 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 | |
| 07/22/2007 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s082ltr.pdf | |
| 06/14/2007 | SUPPL-76 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020563s076ltr.pdf | |
| 09/06/2007 | SUPPL-75 | 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-65 | 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-64 | 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-60 | Supplement |
Label is not available on this site. |
||
| 05/20/2005 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020563s054ltr.pdf | |
| 07/31/2014 | SUPPL-51 | Supplement |
Label is not available on this site. |
||
| 04/21/2004 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr046ltr.pdf | |
| 11/19/2003 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm044ltr.pdf | |
| 09/29/2003 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563scm041ltr.pdf | |
| 06/24/2003 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr040ltr.pdf | |
| 01/16/2004 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563slr036ltr.pdf | |
| 10/25/2002 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 02/05/2002 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 12/17/2001 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
| 04/01/2003 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr032ltr.pdf | |
| 05/11/2001 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 03/26/2001 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 02/12/2003 | SUPPL-27 | Supplement |
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 | |
| 07/07/2000 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 03/14/2000 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 06/02/2004 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20563se3-024ltr.pdf | |
| 05/23/2000 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 02/25/2000 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 01/11/2000 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 05/12/1999 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 01/02/2003 | SUPPL-16 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20563slr016ltr.pdf |
| 02/25/1999 | SUPPL-15 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf | |
| 02/25/1999 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF | |
| 04/04/2000 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF | |
| 04/04/2000 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF | |
| 04/04/2000 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S10-11-12-13LTR.PDF | |
| 09/04/1998 | SUPPL-9 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf |
| 08/06/1998 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 04/29/1997 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-3 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020563a_s003_071697.pdf |
| 03/05/1997 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 01/09/1997 | 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-202 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 07/21/2023 | SUPPL-202 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 07/21/2023 | SUPPL-202 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020563Orig1s202,205747Orig1s028Lbl.pdf | |
| 11/15/2019 | SUPPL-199 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-198 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-198 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 11/15/2019 | SUPPL-196 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s196s198s199,205747s022s025s026lbl.pdf | |
| 08/13/2019 | SUPPL-195 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf | |
| 08/13/2019 | SUPPL-195 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020563s195,205747s021lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 12/11/2018 | SUPPL-190 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s190lbl.pdf | |
| 11/01/2018 | SUPPL-191 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020563s191,205747s018lbl.pdf | |
| 06/06/2017 | SUPPL-176 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf | |
| 06/06/2017 | SUPPL-176 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020563s176lbl.pdf | |
| 01/06/2017 | SUPPL-172 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020563Orig1s172,205747Orig1s008ltr.pdf | |
| 06/12/2015 | SUPPL-163 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s163lbl.pdf | |
| 03/13/2015 | SUPPL-124 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s124lbl.pdf | |
| 02/25/2015 | SUPPL-157 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020563s157lbl.pdf | |
| 03/11/2013 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf | |
| 03/11/2013 | SUPPL-115 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf | |
| 01/30/2013 | SUPPL-127 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s127lbl.pdf | |
| 10/14/2012 | SUPPL-123 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020563s123lbl.pdf | |
| 10/30/2011 | SUPPL-117 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s117lbl.pdf | |
| 05/18/2011 | SUPPL-105 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf | |
| 05/18/2011 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020563s098s105lbl.pdf | |
| 03/16/2009 | SUPPL-91 | 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-75 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s075,021017s040,021018s034lbl.pdf | |
| 08/22/2007 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s065,021017s030,021018s041lbl.pdf | |
| 07/22/2007 | SUPPL-82 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s082lbl.pdf | |
| 06/14/2007 | SUPPL-76 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020563s076lbl.pdf | |
| 05/20/2005 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020563s054lbl.pdf | |
| 06/02/2004 | SUPPL-24 | Efficacy-New Route Of Administration | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563se3-024_humalog_lbl.pdf | |
| 04/21/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr046_humalog_lbl.pdf | |
| 01/16/2004 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20563slr036_humalog_lbl.pdf | |
| 11/19/2003 | SUPPL-44 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563scm044_humalog_lbl.pdf |
| 09/29/2003 | SUPPL-41 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s041lbl.pdf |
| 06/24/2003 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr040_humalog_lbl.pdf | |
| 04/01/2003 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s032lbl.pdf | |
| 02/12/2003 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020563s027lbl.pdf | |
| 04/04/2000 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 04/04/2000 | SUPPL-10 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20563S10-11-12-13LBL.PDF | |
| 02/25/1999 | SUPPL-15 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20563slr015_humalog_lbl.pdf |