Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019640
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HUMATROPE | SOMATROPIN | 2MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| HUMATROPE | SOMATROPIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMATROPE | SOMATROPIN | 6MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMATROPE | SOMATROPIN | 12MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
| HUMATROPE | SOMATROPIN | 24MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/1986 | ORIG-1 | Approval | N/A; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2023 | SUPPL-108 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019640s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019640Orig1s108ltr.pdf | |
| 10/28/2019 | SUPPL-105 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019640Orig1s091, s105ltr.pdf | |
| 12/13/2016 | SUPPL-104 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019640s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019640Orig1s104ltr.pdf | |
| 12/20/2016 | SUPPL-103 | Supplement |
Label is not available on this site. |
||
| 11/10/2014 | SUPPL-98 | Supplement |
Label is not available on this site. |
||
| 09/12/2014 | SUPPL-97 | Supplement |
Label is not available on this site. |
||
| 08/11/2014 | SUPPL-96 | Supplement |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-95 | Supplement |
Label is not available on this site. |
||
| 01/24/2014 | SUPPL-93 | Supplement |
Label is not available on this site. |
||
| 07/30/2014 | SUPPL-92 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019640Orig1s092ltr.pdf | |
| 10/28/2019 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019640Orig1s091, s105ltr.pdf | |
| 05/24/2013 | SUPPL-90 | Supplement |
Label is not available on this site. |
||
| 08/22/2011 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s086ltr.pdf | |
| 02/23/2011 | SUPPL-84 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019640s084ltr.pdf | |
| 07/28/2010 | SUPPL-78 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019640s078ltr.pdf | |
| 01/12/2009 | SUPPL-70 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s070ltr.pdf |
| 03/12/2009 | SUPPL-68 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019640s068ltr.pdf | |
| 11/01/2006 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s058ltr.pdf | |
| 10/26/2006 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf | |
| 10/26/2006 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s047,019640s052ltr.pdf | |
| 06/28/2006 | SUPPL-46 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019640s046ltr.pdf |
| 10/12/2005 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019640s045ltr.pdf | |
| 09/22/2004 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19640s040rev2.pdf | |
| 07/25/2003 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640se1-033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S033_HUMATROPE_AP.pdf | |
| 03/24/2003 | SUPPL-32 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19640slr032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019640_S032_HUMATROPE_AP.pdf |
| 12/04/2002 | SUPPL-31 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640slr031ltr.pdf |
| 05/22/2001 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 01/17/2001 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 02/12/2001 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-25 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19640s025ltr.pdf |
| 09/07/1999 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-22 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019640_s022_HUMATROPE.pdf |
| 10/03/1997 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 06/13/1997 | SUPPL-20 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640_s020_HUMATROPE 5.pdf |
| 03/11/1997 | SUPPL-19 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf |
| 03/11/1997 | SUPPL-18 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019640ap.pdf |
| 08/05/1996 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 11/22/1996 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 11/07/1996 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 12/15/1995 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
| 08/01/1996 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 01/11/1995 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 04/15/1994 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 12/14/1993 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 03/18/1992 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 10/11/1990 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 04/23/1990 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 04/04/1989 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 05/10/1989 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 06/23/1987 | 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 |
|---|---|---|---|---|---|
| 12/08/2023 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019640s108lbl.pdf | |
| 10/28/2019 | SUPPL-105 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf | |
| 10/28/2019 | SUPPL-105 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf | |
| 10/28/2019 | SUPPL-105 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf | |
| 10/28/2019 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019640s091s105lbl.pdf | |
| 12/13/2016 | SUPPL-104 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019640s104lbl.pdf | |
| 07/30/2014 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019640s092lbl.pdf | |
| 08/22/2011 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s086lbl.pdf | |
| 02/23/2011 | SUPPL-84 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019640s084lbl.pdf | |
| 07/28/2010 | SUPPL-78 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019640s078_2lbl.pdf | |
| 03/12/2009 | SUPPL-68 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019640s068lbl.pdf | |
| 11/01/2006 | SUPPL-58 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s058lbl.pdf | |
| 10/26/2006 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf | |
| 10/26/2006 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf | |
| 10/26/2006 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019640s047,019640s052lbl.pdf | |
| 10/12/2005 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019640s045lbl.pdf | |
| 09/22/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19640s040lbl.pdf | |
| 07/25/2003 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19640se1-033_humatropen_lbl.pdf |
HUMATROPE
There are no Therapeutic Equivalents.