Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 019764
Company: EMD SERONO
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf | |
| 10/31/2007 | SUPPL-35 | Labeling-Container/Carton Labels | 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.