Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 STANDARD; 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 Labeling-Package Insert 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 Labeling-Package Insert 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 Labeling 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 Efficacy-Labeling Change With Clinical Data 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 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf
06/28/2005 SUPPL-20 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf
09/17/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/02/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/13/2000 SUPPL-16 Efficacy-New Dosing Regimen 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 Labeling

Label is not available on this site.

11/03/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-13 Efficacy-Labeling Change With Clinical Data 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 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1997 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

08/07/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1995 SUPPL-7 Labeling

Label is not available on this site.

09/22/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1995 SUPPL-5 Labeling

Label is not available on this site.

02/01/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/03/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/03/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/21/1994 SUPPL-1 Manufacturing (CMC)

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-20 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.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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