Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020280
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENOTROPIN SOMATROPIN 5.8MG/VIAL INJECTABLE;INJECTION Prescription BX Yes Yes
GENOTROPIN SOMATROPIN 13.8MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.2MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.4MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.6MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.5MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 0.8MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.2MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.4MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.6MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 1.8MG/VIAL INJECTABLE;INJECTION Prescription None Yes No
GENOTROPIN PRESERVATIVE FREE SOMATROPIN 2MG/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
08/24/1995 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-88 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

06/16/2016 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

12/28/2015 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

09/06/2016 SUPPL-79 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

02/06/2012 SUPPL-72 Labeling 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling 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 Labeling-Container/Carton Labels, Labeling-Package Insert 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 Labeling-Package Insert 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 Efficacy-New Indication 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 Labeling 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 Labeling-Package Insert 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 Efficacy-New Indication 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 Labeling 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 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2003 SUPPL-40 Manufacturing (CMC)-Control 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 Manufacturing (CMC)

Label is not available on this site.

03/28/2003 SUPPL-38 Manufacturing (CMC) 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 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/2001 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

07/09/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

01/26/2001 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/2000 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/07/2000 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

07/25/2001 SUPPL-31 Efficacy-New Indication 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 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/2000 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/18/2000 SUPPL-28 Labeling

Label is not available on this site.

07/31/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2000 SUPPL-25 Labeling

Label is not available on this site.

05/12/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2000 SUPPL-23 Efficacy-New Indication 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 Manufacturing (CMC)

Label is not available on this site.

07/11/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/19/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1999 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/30/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/05/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1998 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1997 SUPPL-8 Efficacy-New Indication 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 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/24/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1996 SUPPL-3 Labeling

Label is not available on this site.

04/24/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/20/1995 SUPPL-1 Labeling

Label is not available on this site.

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

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