Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019640
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMATROPE SOMATROPIN 2MG/VIAL INJECTABLE;INJECTION Discontinued None No No
HUMATROPE SOMATROPIN 5MG/VIAL INJECTABLE;INJECTION Prescription None No No
HUMATROPE SOMATROPIN 6MG/VIAL INJECTABLE;INJECTION Prescription None No No
HUMATROPE SOMATROPIN 12MG/VIAL INJECTABLE;INJECTION Prescription None No No
HUMATROPE SOMATROPIN 24MG/VIAL INJECTABLE;INJECTION Prescription 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
10/16/1986 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
10/28/2019 SUPPL-105 Supplement

Label is not available on this site.

12/13/2016 SUPPL-104 Supplement

Label is not available on this site.

12/20/2016 SUPPL-103 Supplement

Label is not available on this site.

11/10/2014 SUPPL-98 Supplement

Label is not available on this site.

09/12/2014 SUPPL-97 Supplement

Label is not available on this site.

08/11/2014 SUPPL-96 Supplement

Label is not available on this site.

04/11/2014 SUPPL-95 Supplement

Label is not available on this site.

01/24/2014 SUPPL-93 Supplement

Label is not available on this site.

07/30/2014 SUPPL-92 Supplement

Label is not available on this site.

10/28/2019 SUPPL-91 Supplement

Label is not available on this site.

05/24/2013 SUPPL-90 Supplement

Label is not available on this site.

08/22/2011 SUPPL-86 Supplement

Label is not available on this site.

02/23/2011 SUPPL-84 Supplement

Label is not available on this site.

07/28/2010 SUPPL-78 Supplement

Label is not available on this site.

01/12/2009 SUPPL-70 Supplement

Label is not available on this site.

03/12/2009 SUPPL-68 Supplement

Label is not available on this site.

11/01/2006 SUPPL-58 Supplement

Label is not available on this site.

10/26/2006 SUPPL-52 Supplement

Label is not available on this site.

10/26/2006 SUPPL-47 Supplement

Label is not available on this site.

06/28/2006 SUPPL-46 Supplement

Label is not available on this site.

10/12/2005 SUPPL-45 Supplement

Label is not available on this site.

09/22/2004 SUPPL-40 Supplement

Label is not available on this site.

07/25/2003 SUPPL-33 Supplement

Label is not available on this site.

03/24/2003 SUPPL-32 Supplement

Label is not available on this site.

12/04/2002 SUPPL-31 Supplement

Label is not available on this site.

05/22/2001 SUPPL-30 Supplement

Label is not available on this site.

05/01/2001 SUPPL-29 Supplement

Label is not available on this site.

01/17/2001 SUPPL-28 Supplement

Label is not available on this site.

02/12/2001 SUPPL-26 Supplement

Label is not available on this site.

06/10/2002 SUPPL-25 Supplement

Label is not available on this site.

09/07/1999 SUPPL-24 Supplement

Label is not available on this site.

02/04/1999 SUPPL-22 Supplement

Label is not available on this site.

10/03/1997 SUPPL-21 Supplement

Label is not available on this site.

06/13/1997 SUPPL-20 Supplement

Label is not available on this site.

03/11/1997 SUPPL-19 Supplement

Label is not available on this site.

03/11/1997 SUPPL-18 Supplement

Label is not available on this site.

08/05/1996 SUPPL-17 Supplement

Label is not available on this site.

11/22/1996 SUPPL-16 Supplement

Label is not available on this site.

11/07/1996 SUPPL-15 Supplement

Label is not available on this site.

12/15/1995 SUPPL-14 Supplement

Label is not available on this site.

08/01/1996 SUPPL-13 Supplement

Label is not available on this site.

09/22/1995 SUPPL-12 Supplement

Label is not available on this site.

09/13/1995 SUPPL-11 Supplement

Label is not available on this site.

01/11/1995 SUPPL-10 Supplement

Label is not available on this site.

04/15/1994 SUPPL-9 Supplement

Label is not available on this site.

11/18/1993 SUPPL-8 Supplement

Label is not available on this site.

12/14/1993 SUPPL-7 Supplement

Label is not available on this site.

03/18/1992 SUPPL-6 Supplement

Label is not available on this site.

10/11/1990 SUPPL-5 Supplement

Label is not available on this site.

04/23/1990 SUPPL-4 Supplement

Label is not available on this site.

04/04/1989 SUPPL-3 Supplement

Label is not available on this site.

05/10/1989 SUPPL-2 Supplement

Label is not available on this site.

06/23/1987 SUPPL-1 Supplement

Label is not available on this site.

HUMATROPE

There are no Therapeutic Equivalents.

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