Drugs@FDA: FDA-Approved Drugs

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

12/13/2016 SUPPL-90 Supplement

Label is not available on this site.

12/13/2016 SUPPL-89 Supplement

Label is not available on this site.

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 is not available on this site.

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 is not available on this site.

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 is not available on this site.

08/31/2009 SUPPL-48 Supplement

Label is not available on this site.

08/30/2007 SUPPL-44 Supplement

Label is not available on this site.

07/13/2007 SUPPL-40 Supplement

Label is not available on this site.

11/27/2006 SUPPL-35 Supplement

Label is not available on this site.

09/21/2006 SUPPL-34 Supplement

Label is not available on this site.

08/24/2005 SUPPL-31 Supplement

Label is not available on this site.

07/09/2004 SUPPL-30 Supplement

Label is not available on this site.

02/11/2005 SUPPL-29 Supplement

Label is not available on this site.

08/29/2003 SUPPL-27 Supplement

Label is not available on this site.

12/01/2003 SUPPL-26 Supplement

Label is not available on this site.

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

Label is not available on this site.

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.

SEROSTIM

There are no Therapeutic Equivalents.

SEROSTIM LQ

There are no Therapeutic Equivalents.

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