Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019640
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMATROPE SOMATROPIN RECOMBINANT 2MG/VIAL INJECTABLE;INJECTION Discontinued None No No
HUMATROPE SOMATROPIN RECOMBINANT 5MG/VIAL INJECTABLE;INJECTION Prescription BX Yes Yes
HUMATROPE SOMATROPIN RECOMBINANT 6MG/VIAL INJECTABLE;INJECTION Prescription BX Yes No
HUMATROPE SOMATROPIN RECOMBINANT 12MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
HUMATROPE SOMATROPIN RECOMBINANT 24MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
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 Type 5 - New Formulation or New Manufacturer PRIORITY; 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
10/28/2019 SUPPL-105 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert 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 Labeling-Patient Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

11/10/2014 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

04/11/2014 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

01/24/2014 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

07/30/2014 SUPPL-92 Labeling-Package Insert 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 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

08/22/2011 SUPPL-86 Labeling-Package Insert 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 Labeling 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 Labeling-Package Insert 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Efficacy-New Indication 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 Efficacy-New Indication 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Labeling 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Efficacy-Labeling Change With Clinical Data 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 Labeling 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 Efficacy-New Indication 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 Labeling 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 Labeling 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 Manufacturing (CMC)

Label is not available on this site.

05/01/2001 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2001 SUPPL-26 Labeling

Label is not available on this site.

06/10/2002 SUPPL-25 Labeling 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 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-22 Manufacturing (CMC)-Formulation 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 Labeling

Label is not available on this site.

06/13/1997 SUPPL-20 Manufacturing (CMC)-Control 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 Labeling 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 Efficacy-New Indication 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 Labeling

Label is not available on this site.

11/22/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1996 SUPPL-15 Labeling

Label is not available on this site.

12/15/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/01/1996 SUPPL-13 Efficacy-New Indication

Label is not available on this site.

09/22/1995 SUPPL-12 Labeling

Label is not available on this site.

09/13/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1994 SUPPL-9 Efficacy-New Dosing Regimen

Label is not available on this site.

11/18/1993 SUPPL-8 Labeling

Label is not available on this site.

12/14/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1992 SUPPL-6 Labeling

Label is not available on this site.

10/11/1990 SUPPL-5 Labeling

Label is not available on this site.

04/23/1990 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1989 SUPPL-3 Labeling

Label is not available on this site.

05/10/1989 SUPPL-2 Efficacy-New Route Of Administration

Label is not available on this site.

06/23/1987 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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.

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