Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 019764
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 is not available on this site.

12/13/2016 SUPPL-83 Supplement

Label is not available on this site.

04/21/2016 SUPPL-80 Supplement

Label is not available on this site.

01/17/2017 SUPPL-79 Supplement

Label is not available on this site.

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 is not available on this site.

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 is not available on this site.

08/27/2007 SUPPL-39 Supplement

Label is not available on this site.

08/22/2007 SUPPL-37 Supplement

Label is not available on this site.

10/31/2007 SUPPL-35 Supplement

Label is not available on this site.

03/05/2007 SUPPL-34 Supplement

Label is not available on this site.

01/16/2007 SUPPL-30 Supplement

Label is not available on this site.

07/09/2004 SUPPL-25 Supplement

Label is not available on this site.

07/01/2003 SUPPL-23 Supplement

Label is not available on this site.

11/01/2004 SUPPL-20 Supplement

Label is not available on this site.

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

Label is not available on this site.

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.

SAIZEN

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