Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019676
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTROPIN SOMATROPIN [rDNA origin] N/A 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
03/09/1994 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
12/13/2016 SUPPL-44 Supplement

Label is not available on this site.

04/10/2012 SUPPL-42 Supplement

Label is not available on this site.

02/15/2007 SUPPL-30 Supplement

Label is not available on this site.

02/23/2006 SUPPL-26 Supplement

Label is not available on this site.

06/28/2005 SUPPL-21 Supplement

Label is not available on this site.

06/28/2005 SUPPL-20 Supplement

Label is not available on this site.

09/17/2001 SUPPL-18 Supplement

Label is not available on this site.

05/02/2001 SUPPL-17 Supplement

Label is not available on this site.

04/13/2000 SUPPL-16 Supplement

Label is not available on this site.

11/24/1999 SUPPL-15 Supplement

Label is not available on this site.

11/03/1999 SUPPL-14 Supplement

Label is not available on this site.

12/01/1999 SUPPL-13 Supplement

Label is not available on this site.

09/25/1998 SUPPL-12 Supplement

Label is not available on this site.

09/25/1998 SUPPL-11 Supplement

Label is not available on this site.

09/12/1997 SUPPL-10 Supplement

Label is not available on this site.

12/15/1997 SUPPL-9 Supplement

Label is not available on this site.

08/07/1996 SUPPL-8 Supplement

Label is not available on this site.

08/21/1995 SUPPL-7 Supplement

Label is not available on this site.

09/22/1995 SUPPL-6 Supplement

Label is not available on this site.

08/25/1995 SUPPL-5 Supplement

Label is not available on this site.

02/01/1996 SUPPL-4 Supplement

Label is not available on this site.

02/03/1995 SUPPL-3 Supplement

Label is not available on this site.

08/03/1994 SUPPL-2 Supplement

Label is not available on this site.

07/21/1994 SUPPL-1 Supplement

Label is not available on this site.

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