Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019764
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SAIZEN SOMATROPIN RECOMBINANT 6MG/VIAL INJECTABLE;INJECTION Discontinued None No No
SAIZEN SOMATROPIN RECOMBINANT 5MG/VIAL INJECTABLE;INJECTION Prescription BX Yes No
SAIZEN SOMATROPIN RECOMBINANT 8.8MG/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
SAIZEN SOMATROPIN RECOMBINANT 4MG/VIAL INJECTABLE;INJECTION Discontinued 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
10/08/1996 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; 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
05/08/2017 SUPPL-86 Labeling-Proprietary Name Change, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019764Orig1s086ltr.pdf
12/13/2016 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019764Orig1s083ltr.pdf
04/21/2016 SUPPL-80 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s079lbl.pdf
01/17/2017 SUPPL-79 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s079lbl.pdf
06/12/2015 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

03/03/2015 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019764Orig1s072ltr.pdf
11/18/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

04/05/2013 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

02/20/2013 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

02/13/2013 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

06/11/2015 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

02/07/2013 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

11/13/2013 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

01/19/2013 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

01/19/2013 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/19/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

01/18/2013 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

01/11/2013 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

01/11/2013 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

04/03/2012 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf
08/27/2007 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s039ltr.pdf
08/22/2007 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s037ltr.pdf
10/31/2007 SUPPL-35 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s035ltr.pdf
03/05/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s034ltr.pdf
01/16/2007 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s030ltr.pdf
07/09/2004 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf
07/01/2003 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19764slr023ltr.pdf
11/01/2004 SUPPL-20 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764s020ltr.pdf
10/17/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/20/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/03/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/03/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/17/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/2000 SUPPL-11 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019764_s011_SAIZEN INJECTION.pdf
04/11/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/26/2000 SUPPL-9 Labeling

Label is not available on this site.

06/07/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/28/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/04/2000 SUPPL-6 Labeling

Label is not available on this site.

02/11/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/09/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/29/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/09/1996 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
05/08/2017 SUPPL-86 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf
05/08/2017 SUPPL-86 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf
01/17/2017 SUPPL-79 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s079lbl.pdf
12/13/2016 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s083lbl.pdf
04/21/2016 SUPPL-80 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s079lbl.pdf
06/18/2014 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf
04/03/2012 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf
10/31/2007 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf
10/31/2007 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf
08/27/2007 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf
08/22/2007 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf
03/05/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf
01/16/2007 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf
01/16/2007 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf
11/01/2004 SUPPL-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf
07/09/2004 SUPPL-25 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf
07/01/2003 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf

SAIZEN

There are no Therapeutic Equivalents.

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