Drugs@FDA: FDA-Approved Drugs
Company: EMD SERONO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SAIZEN | SOMATROPIN | 6MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
SAIZEN | SOMATROPIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
SAIZEN | SOMATROPIN | 8.8MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | No |
SAIZEN | SOMATROPIN | 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 | 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 |
---|---|---|---|---|---|
05/08/2017 | SUPPL-86 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
01/17/2017 | SUPPL-79 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s079lbl.pdf | |
06/12/2015 | SUPPL-78 | Supplement |
Label is not available on this site. |
||
03/03/2015 | SUPPL-77 | Supplement |
Label is not available on this site. |
||
02/16/2015 | SUPPL-76 | Supplement |
Label is not available on this site. |
||
08/11/2014 | SUPPL-74 | Supplement |
Label is not available on this site. |
||
09/30/2014 | SUPPL-73 | Supplement |
Label is not available on this site. |
||
06/18/2014 | SUPPL-72 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
12/12/2013 | SUPPL-70 | Supplement |
Label is not available on this site. |
||
04/05/2013 | SUPPL-69 | Supplement |
Label is not available on this site. |
||
02/20/2013 | SUPPL-67 | Supplement |
Label is not available on this site. |
||
02/15/2013 | SUPPL-66 | Supplement |
Label is not available on this site. |
||
02/15/2013 | SUPPL-65 | Supplement |
Label is not available on this site. |
||
01/31/2013 | SUPPL-64 | Supplement |
Label is not available on this site. |
||
02/13/2013 | SUPPL-63 | Supplement |
Label is not available on this site. |
||
06/11/2015 | SUPPL-62 | Supplement |
Label is not available on this site. |
||
02/08/2013 | SUPPL-61 | Supplement |
Label is not available on this site. |
||
02/07/2013 | SUPPL-60 | Supplement |
Label is not available on this site. |
||
11/13/2013 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
01/19/2013 | SUPPL-58 | Supplement |
Label is not available on this site. |
||
01/19/2013 | SUPPL-57 | Supplement |
Label is not available on this site. |
||
01/19/2013 | SUPPL-56 | Supplement |
Label is not available on this site. |
||
01/18/2013 | SUPPL-54 | Supplement |
Label is not available on this site. |
||
01/11/2013 | SUPPL-53 | Supplement |
Label is not available on this site. |
||
01/11/2013 | SUPPL-52 | 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/2012/019764s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf | |
08/27/2007 | SUPPL-39 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | 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 | |
07/01/2003 | SUPPL-23 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
12/31/2002 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
12/20/2002 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
12/03/2001 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
09/06/2002 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
07/19/2001 | SUPPL-14 | Supplement |
Label is not available on this site. |
||
05/03/2001 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
08/17/2000 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
07/19/2000 | SUPPL-11 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
07/26/2000 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
06/07/2000 | 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. |
||
02/11/1999 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
07/09/1998 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
08/29/2000 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
01/21/1998 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
12/09/1996 | 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 |
---|---|---|---|---|---|
05/08/2017 | SUPPL-86 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019764s086lbl.pdf | |
05/08/2017 | SUPPL-86 | Labeling-Proprietary Name Change | 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/2016/019764s079lbl.pdf |
12/13/2016 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019764s083lbl.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.