Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
NUTROPIN AQ NUSPIN SOMATROPIN 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
NUTROPIN AQ NUSPIN SOMATROPIN 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Prescription None Yes Yes
NUTROPIN AQ PEN SOMATROPIN 10MG/2ML (5MG/ML) INJECTABLE;INJECTION Discontinued None Yes No
NUTROPIN AQ PEN SOMATROPIN 20MG/2ML (10MG/ML) INJECTABLE;INJECTION Discontinued None Yes 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 Type 3 - New Dosage Form STANDARD

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 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020522s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020522Orig1s061ltr.pdf
11/30/2016 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

05/18/2016 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/17/2016 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

02/26/2016 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

01/13/2016 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

06/23/2015 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

05/26/2015 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

05/15/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/18/2014 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020522Orig1s051ltr.pdf
09/17/2013 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/10/2012 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf
01/03/2008 SUPPL-37 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf
01/03/2008 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf
02/15/2007 SUPPL-33 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
11/18/2005 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s027ltr.pdf
01/03/2008 SUPPL-26 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf
06/28/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf
06/28/2005 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf
04/22/2002 SUPPL-17 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20522s017.pdf
09/17/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/17/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2000 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20522S13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522s013_Somatropin.cfm
10/13/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020522_S011_NUTROPIN FOR INJ.pdf
11/03/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/01/1999 SUPPL-9 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20522S9LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20522S9.PDF
09/25/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/26/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/09/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1997 SUPPL-4 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522a_s004.pdf
09/12/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1997 SUPPL-2 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522_s002ap.pdf
08/07/1996 SUPPL-1 Manufacturing (CMC)-Control

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-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020522s061lbl.pdf
06/18/2014 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf
04/10/2012 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf
01/03/2008 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf
01/03/2008 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf
01/03/2008 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf
01/03/2008 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf
01/03/2008 SUPPL-26 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf
02/15/2007 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf
11/18/2005 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf
06/28/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf
06/28/2005 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf
04/22/2002 SUPPL-17 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf
04/13/2000 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf

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