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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 (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019676Orig1s044,020168Orig1s024ltr.pdf
04/10/2012 SUPPL-42 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf
02/15/2007 SUPPL-30 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf
02/23/2006 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019676s026ltr.pdf
06/28/2005 SUPPL-21 Supplement Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf
06/28/2005 SUPPL-20 Supplement Label (PDF)
Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf
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 (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19676S16LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676s016_Nutropin.cfm
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 Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin.cfm
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/13/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019676s044,020168s024lbl.pdf
04/10/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf
02/15/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf
02/23/2006 SUPPL-26 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf
06/28/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf
06/28/2005 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf
06/28/2005 SUPPL-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf
06/28/2005 SUPPL-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf
04/13/2000 SUPPL-16 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf
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