Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 020280
Company: PHARMACIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENOTROPIN SOMATROPIN 5.8MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN SOMATROPIN 13.8MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.2MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.4MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.6MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.8MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.2MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.4MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.6MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.8MG/VIAL INJECTABLE;INJECTION Prescription None No No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 2MG/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
08/24/1995 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/08/2020 SUPPL-90 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020280Orig1s090ltr.pdf
12/13/2016 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s088ltr.pdf
01/27/2017 SUPPL-87 Supplement

Label is not available on this site.

06/16/2016 SUPPL-84 Supplement

Label is not available on this site.

12/28/2015 SUPPL-82 Supplement

Label is not available on this site.

09/10/2015 SUPPL-81 Supplement

Label is not available on this site.

02/16/2015 SUPPL-80 Supplement

Label is not available on this site.

09/06/2016 SUPPL-79 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020280Orig1s079ltr.pdf
06/22/2015 SUPPL-78 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020280Orig1s078ltr.pdf
09/25/2014 SUPPL-77 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020280Orig1s077ltr.pdf
10/17/2013 SUPPL-75 Supplement

Label is not available on this site.

04/19/2013 SUPPL-74 Supplement

Label is not available on this site.

02/06/2012 SUPPL-72 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020280s072ltr.pdf
05/17/2011 SUPPL-71 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020280s071ltr.pdf
02/02/2010 SUPPL-68 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020280s068ltr.pdf
12/15/2008 SUPPL-66 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s066ltr.pdf
05/20/2009 SUPPL-64 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s064ltr.pdf
01/05/2009 SUPPL-61 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020280s061ltr.pdf
06/12/2008 SUPPL-60 Supplement Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020280s060ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf
03/14/2007 SUPPL-57 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s057ltr.pdf
07/22/2007 SUPPL-55 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020280s055ltr.pdf
04/27/2006 SUPPL-49 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020280s049LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020280_s049_genotropin_medr.pdf
10/31/2003 SUPPL-44 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280slr044ltr.pdf
11/05/2002 SUPPL-41 Supplement

Label is not available on this site.

05/12/2003 SUPPL-40 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scs040ltr.pdf
08/15/2002 SUPPL-39 Supplement

Label is not available on this site.

03/28/2003 SUPPL-38 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20280scm038ltr.pdf
01/29/2002 SUPPL-37 Supplement

Label is not available on this site.

09/21/2001 SUPPL-36 Supplement

Label is not available on this site.

07/09/2001 SUPPL-35 Supplement

Label is not available on this site.

01/26/2001 SUPPL-34 Supplement

Label is not available on this site.

12/08/2000 SUPPL-33 Supplement

Label is not available on this site.

11/07/2000 SUPPL-32 Supplement

Label is not available on this site.

07/25/2001 SUPPL-31 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20280s31ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-280S031_Genotropin.cfm
07/21/2000 SUPPL-30 Supplement

Label is not available on this site.

10/05/2000 SUPPL-29 Supplement

Label is not available on this site.

08/18/2000 SUPPL-28 Supplement

Label is not available on this site.

07/31/2000 SUPPL-27 Supplement

Label is not available on this site.

05/26/2000 SUPPL-26 Supplement

Label is not available on this site.

07/11/2000 SUPPL-25 Supplement

Label is not available on this site.

05/12/2000 SUPPL-24 Supplement

Label is not available on this site.

06/20/2000 SUPPL-23 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF
04/11/2000 SUPPL-22 Supplement

Label is not available on this site.

07/11/2000 SUPPL-21 Supplement

Label is not available on this site.

01/19/2000 SUPPL-20 Supplement

Label is not available on this site.

04/30/1999 SUPPL-18 Supplement

Label is not available on this site.

04/27/1999 SUPPL-17 Supplement

Label is not available on this site.

02/24/1999 SUPPL-16 Supplement

Label is not available on this site.

07/30/1998 SUPPL-15 Supplement

Label is not available on this site.

04/30/1999 SUPPL-13 Supplement

Label is not available on this site.

08/18/1998 SUPPL-12 Supplement

Label is not available on this site.

08/04/1998 SUPPL-11 Supplement

Label is not available on this site.

01/05/1998 SUPPL-10 Supplement

Label is not available on this site.

01/27/1998 SUPPL-9 Supplement

Label is not available on this site.

10/31/1997 SUPPL-8 Supplement Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020280s008.pdf
10/23/1996 SUPPL-7 Supplement

Label is not available on this site.

11/19/1996 SUPPL-6 Supplement

Label is not available on this site.

07/15/1996 SUPPL-5 Supplement

Label is not available on this site.

05/24/1996 SUPPL-4 Supplement

Label is not available on this site.

04/19/1996 SUPPL-3 Supplement

Label is not available on this site.

04/24/1996 SUPPL-2 Supplement

Label is not available on this site.

12/20/1995 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
01/08/2020 SUPPL-90 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20280S23LTR.PDF
12/13/2016 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s088lbl.pdf
09/06/2016 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020280s079lbl.pdf
06/22/2015 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020280s078lbl.pdf
09/25/2014 SUPPL-77 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020280s077lbl.pdf
02/06/2012 SUPPL-72 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020280s072lbl.pdf
05/17/2011 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf
02/02/2010 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020280s068lbl.pdf
05/20/2009 SUPPL-64 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf
05/20/2009 SUPPL-64 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf
01/05/2009 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s061lbl.pdf
12/15/2008 SUPPL-66 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s066lbl.pdf
06/12/2008 SUPPL-60 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020280s060lbl.pdf
07/22/2007 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s055lbl.pdf
03/14/2007 SUPPL-57 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020280s057lbl.pdf
04/27/2006 SUPPL-49 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020280s049lbl.pdf
05/12/2003 SUPPL-40 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf
07/25/2001 SUPPL-31 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20280s31lbl.pdf

GENOTROPIN

There are no Therapeutic Equivalents.

GENOTROPIN PRESERVATIVE FREE

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English