Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021148
Company: NOVO NORDISK INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORDITROPIN SOMATROPIN 5MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN SOMATROPIN 10MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN SOMATROPIN 15MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN FLEXPRO SOMATROPIN 5MG/1.5ML INJECTABLE;INJECTION Prescription BX No No
NORDITROPIN FLEXPRO SOMATROPIN 10MG/1.5ML INJECTABLE;INJECTION Prescription BX No No
NORDITROPIN FLEXPRO SOMATROPIN 15MG/1.5ML INJECTABLE;INJECTION Prescription None No No
NORDITROPIN FLEXPRO SOMATROPIN 30MG/3ML INJECTABLE;INJECTION Prescription None No No
NORDITROPIN NORDIFLEX SOMATROPIN 5MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN NORDIFLEX SOMATROPIN 10MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN NORDIFLEX SOMATROPIN 15MG/1.5ML INJECTABLE;INJECTION Discontinued None No No
NORDITROPIN NORDIFLEX SOMATROPIN 30MG/3ML 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
06/20/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21148lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21148ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-148_Norditropin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/29/2017 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021148s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021148Orig1s049ltr.pdf
12/13/2016 SUPPL-48 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021148s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021148Orig1s048ltr.pdf
01/12/2017 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

06/23/2016 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

01/13/2016 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

07/07/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s044ltr.pdf
06/12/2015 SUPPL-43 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s043ltr.pdf
01/23/2015 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s042ltr.pdf
09/25/2014 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021148s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021148Orig1s041ltr.pdf
05/15/2013 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/14/2013 SUPPL-39 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021148Orig1s039ltr.pdf
02/23/2018 SUPPL-38 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021148Orig1s037s038ltr.pdf
02/23/2018 SUPPL-37 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021148Orig1s037s038ltr.pdf
05/25/2011 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021148s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021148s035ltr.pdf
06/12/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/01/2010 SUPPL-27 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf
03/10/2009 SUPPL-25 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021148s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021148s025ltr.pdf
10/31/2008 SUPPL-23 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021148s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021148s023ltr.pdf
09/14/2007 SUPPL-18 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s018ltr.pdf
09/20/2007 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s017ltr.pdf
05/31/2007 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s016ltr.pdf
02/13/2007 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021148s015ltr.pdf
09/01/2006 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021148s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021148s013ltr.pdf
11/01/2004 SUPPL-7 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s007ltr.pdf
10/01/2004 SUPPL-6 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21148s006ltr.pdf
04/25/2005 SUPPL-4 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021148s004ltr.pdf
08/16/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/2001 SUPPL-1 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21148S1ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2018 SUPPL-38 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf
02/23/2018 SUPPL-37 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021148s037s038lbl.pdf
08/29/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021148s049lbl.pdf
12/13/2016 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021148s048lbl.pdf
12/13/2016 SUPPL-48 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021148s048lbl.pdf
07/07/2015 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s044lbl.pdf
06/12/2015 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf
01/23/2015 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s042lbl.pdf
09/25/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021148s041lbl.pdf
10/14/2013 SUPPL-39 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf
10/14/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf
10/14/2013 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021148s039lbl.pdf
05/25/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021148s035lbl.pdf
03/01/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf
03/01/2010 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf
03/10/2009 SUPPL-25 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021148s025lbl.pdf
10/31/2008 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021148s023lbl.pdf
09/20/2007 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s017lbl.pdf
09/14/2007 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf
09/14/2007 SUPPL-18 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf
05/31/2007 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s016lbl.pdf
02/13/2007 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s015lbl.pdf
09/01/2006 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021148s013lbl.pdf
06/20/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21148lbl.pdf

NORDITROPIN

There are no Therapeutic Equivalents.

NORDITROPIN FLEXPRO

There are no Therapeutic Equivalents.

NORDITROPIN NORDIFLEX

There are no Therapeutic Equivalents.

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