Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020604
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEROSTIM SOMATROPIN 6MG/VIAL INJECTABLE;INJECTION Prescription BX No No
SEROSTIM SOMATROPIN 5MG/VIAL INJECTABLE;INJECTION Prescription BX No No
SEROSTIM SOMATROPIN 4MG/VIAL INJECTABLE;INJECTION Prescription None No No
SEROSTIM SOMATROPIN 8.8MG/VIAL INJECTABLE;INJECTION Discontinued None No No
SEROSTIM LQ SOMATROPIN 6MG/0.5ML (6MG/0.5ML) INJECTABLE;SUBCUTANEOUS 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
08/23/1996 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
05/09/2017 SUPPL-93 Labeling-Proprietary Name Change, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s093ltr.pdf
12/13/2016 SUPPL-90 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s090ltr.pdf
12/13/2016 SUPPL-89 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020604Orig1s089ltr.pdf
08/11/2014 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

09/30/2014 SUPPL-81 Manufacturing (CMC)

Label is not available on this site.

09/17/2014 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020604Orig1s078ltr.pdf
12/12/2013 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

12/11/2013 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

05/24/2017 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020604Orig1s074ltr.pdf
04/05/2013 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

02/28/2013 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

01/31/2013 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

02/08/2013 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

11/20/2012 SUPPL-58 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/2012/020604s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf
08/31/2009 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020604s048ltr.pdf
08/30/2007 SUPPL-44 Labeling Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf
07/13/2007 SUPPL-40 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020604_s040_serostim.pdf
11/27/2006 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s035ltr.pdf
09/21/2006 SUPPL-34 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s034ltr.pdf
08/24/2005 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020604s031ltr.pdf
07/09/2004 SUPPL-30 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
02/11/2005 SUPPL-29 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20604s029ltr.pdf
08/29/2003 SUPPL-27 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20604se7-027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_s027_SEROSTIM.pdf
12/01/2003 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_S026_ZORBITIVE.pdf
10/17/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/20/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/03/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/06/2001 SUPPL-16 Labeling

Label is not available on this site.

05/03/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/13/2001 SUPPL-14 Labeling

Label is not available on this site.

08/17/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/2000 SUPPL-12 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020604_s012_SAIZEN INJECTION.pdf
04/11/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/27/2000 SUPPL-10 Labeling

Label is not available on this site.

07/17/2000 SUPPL-9 Labeling

Label is not available on this site.

09/18/2000 SUPPL-8 Manufacturing (CMC)-Expiration Date

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.

07/09/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

01/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1998 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
05/24/2017 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s074lbl.pdf
05/09/2017 SUPPL-93 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf
05/09/2017 SUPPL-93 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020604s093lbl.pdf
12/13/2016 SUPPL-90 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s090lbl.pdf
12/13/2016 SUPPL-89 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020604s089lbl.pdf
06/18/2014 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf
04/03/2012 SUPPL-49 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020604s049lbl.pdf
08/30/2007 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf
08/30/2007 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf
07/13/2007 SUPPL-40 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf
11/27/2006 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf
09/21/2006 SUPPL-34 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf
08/24/2005 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf
02/11/2005 SUPPL-29 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf
07/09/2004 SUPPL-30 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf
12/01/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf
08/29/2003 SUPPL-27 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf

SEROSTIM

There are no Therapeutic Equivalents.

SEROSTIM LQ

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