Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020522
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTROPIN AQ SOMATROPIN 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Discontinued None No No
NUTROPIN AQ NUSPIN SOMATROPIN 5MG/2ML (2.5MG/ML) INJECTABLE;INJECTION Prescription None No No
NUTROPIN AQ NUSPIN SOMATROPIN 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription None No No
NUTROPIN AQ NUSPIN SOMATROPIN 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription None No No
NUTROPIN AQ PEN SOMATROPIN 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Discontinued None No No
NUTROPIN AQ PEN SOMATROPIN 20MG/2ML (10MG/ML) 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
12/29/1995 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-61 Supplement

Label is not available on this site.

11/30/2016 SUPPL-60 Supplement

Label is not available on this site.

05/18/2016 SUPPL-59 Supplement

Label is not available on this site.

03/17/2016 SUPPL-58 Supplement

Label is not available on this site.

02/26/2016 SUPPL-57 Supplement

Label is not available on this site.

01/13/2016 SUPPL-56 Supplement

Label is not available on this site.

06/23/2015 SUPPL-55 Supplement

Label is not available on this site.

05/26/2015 SUPPL-54 Supplement

Label is not available on this site.

05/15/2014 SUPPL-52 Supplement

Label is not available on this site.

06/18/2014 SUPPL-51 Supplement

Label is not available on this site.

09/17/2013 SUPPL-50 Supplement

Label is not available on this site.

07/18/2013 SUPPL-49 Supplement

Label is not available on this site.

04/10/2012 SUPPL-45 Supplement

Label is not available on this site.

01/03/2008 SUPPL-37 Supplement

Label is not available on this site.

01/03/2008 SUPPL-36 Supplement

Label is not available on this site.

02/15/2007 SUPPL-33 Supplement

Label is not available on this site.

11/18/2005 SUPPL-27 Supplement

Label is not available on this site.

01/03/2008 SUPPL-26 Supplement

Label is not available on this site.

06/28/2005 SUPPL-22 Supplement

Label is not available on this site.

06/28/2005 SUPPL-21 Supplement

Label is not available on this site.

04/22/2002 SUPPL-17 Supplement

Label is not available on this site.

09/17/2001 SUPPL-16 Supplement

Label is not available on this site.

05/02/2001 SUPPL-15 Supplement

Label is not available on this site.

09/17/2001 SUPPL-14 Supplement

Label is not available on this site.

04/13/2000 SUPPL-13 Supplement

Label is not available on this site.

10/13/1999 SUPPL-12 Supplement

Label is not available on this site.

11/24/1999 SUPPL-11 Supplement

Label is not available on this site.

11/03/1999 SUPPL-10 Supplement

Label is not available on this site.

12/01/1999 SUPPL-9 Supplement

Label is not available on this site.

09/25/1998 SUPPL-8 Supplement

Label is not available on this site.

09/25/1998 SUPPL-7 Supplement

Label is not available on this site.

10/26/1998 SUPPL-6 Supplement

Label is not available on this site.

07/09/1998 SUPPL-5 Supplement

Label is not available on this site.

12/17/1997 SUPPL-4 Supplement

Label is not available on this site.

09/12/1997 SUPPL-3 Supplement

Label is not available on this site.

03/24/1997 SUPPL-2 Supplement

Label is not available on this site.

08/07/1996 SUPPL-1 Supplement

Label is not available on this site.

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