Drugs@FDA: FDA-Approved Drugs
Company: EMD SERONO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SEROSTIM | SOMATROPIN | 6MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
SEROSTIM | SOMATROPIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | None | 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 | N/A; 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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
09/30/2014 | SUPPL-81 | Supplement |
Label is not available on this site. |
||
09/17/2014 | SUPPL-80 | Supplement |
Label is not available on this site. |
||
06/18/2014 | SUPPL-78 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
12/11/2013 | SUPPL-75 | Supplement |
Label is not available on this site. |
||
05/24/2017 | SUPPL-74 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
02/28/2013 | SUPPL-71 | Supplement |
Label is not available on this site. |
||
02/15/2013 | SUPPL-68 | Supplement |
Label is not available on this site. |
||
01/31/2013 | SUPPL-67 | Supplement |
Label is not available on this site. |
||
02/08/2013 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
11/20/2012 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
04/03/2012 | SUPPL-49 | Supplement |
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 | Supplement |
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 | Supplement |
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/2007/020604s044_v2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf | |
07/13/2007 | SUPPL-40 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
12/31/2002 | SUPPL-22 | Supplement |
Label is not available on this site. |
||
12/20/2002 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
12/03/2001 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
11/19/2001 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
09/06/2002 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
07/19/2001 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
09/06/2001 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
05/03/2001 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
06/13/2001 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
08/17/2000 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
07/19/2000 | SUPPL-12 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
10/27/2000 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
07/17/2000 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
09/18/2000 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
03/28/2000 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
04/04/2000 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
07/09/1998 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
07/09/1998 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
01/21/1998 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
07/25/1997 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
01/16/1998 | 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 |
---|---|---|---|---|---|
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.