Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020168
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUTROPIN SOMATROPIN 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
NUTROPIN SOMATROPIN 10MG/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
11/17/1993 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-24 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.

08/28/2000 SUPPL-16 Supplement

Label is not available on this site.

11/03/1999 SUPPL-15 Supplement

Label is not available on this site.

09/25/1998 SUPPL-14 Supplement

Label is not available on this site.

09/25/1998 SUPPL-13 Supplement

Label is not available on this site.

09/12/1997 SUPPL-12 Supplement

Label is not available on this site.

08/07/1996 SUPPL-11 Supplement

Label is not available on this site.

08/21/1995 SUPPL-10 Supplement

Label is not available on this site.

02/01/1996 SUPPL-9 Supplement

Label is not available on this site.

04/05/1996 SUPPL-8 Supplement

Label is not available on this site.

09/22/1995 SUPPL-7 Supplement

Label is not available on this site.

08/25/1995 SUPPL-6 Supplement

Label is not available on this site.

08/03/1994 SUPPL-5 Supplement

Label is not available on this site.

07/21/1994 SUPPL-4 Supplement

Label is not available on this site.

04/15/1994 SUPPL-3 Supplement

Label is not available on this site.

04/15/1994 SUPPL-2 Supplement

Label is not available on this site.

03/15/1994 SUPPL-1 Supplement

Label is not available on this site.

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