Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 021148
Company: NOVO NORDISK INC
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 | None | No | No |
| NORDITROPIN FLEXPRO | SOMATROPIN | 10MG/1.5ML | INJECTABLE;INJECTION | Prescription | None | 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 | N/A |
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 |
|---|---|---|---|---|---|
| 03/09/2020 | SUPPL-53 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021148s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021148Orig1s053ltr.pdf | |
| 08/29/2017 | SUPPL-49 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 06/23/2016 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 01/13/2016 | SUPPL-45 | Supplement |
Label is not available on this site. |
||
| 07/07/2015 | SUPPL-44 | Supplement |
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 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021148Orig1s043ltr.pdf |
| 01/23/2015 | SUPPL-42 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 10/14/2013 | SUPPL-39 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf | |
| 03/01/2010 | SUPPL-27 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf | |
| 03/10/2009 | SUPPL-25 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-1 | Supplement |
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 |
|---|---|---|---|---|---|
| 03/09/2020 | SUPPL-53 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021148s053lbl.pdf | |
| 03/09/2020 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021148s053lbl.pdf | |
| 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-28 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf |
| 06/12/2015 | SUPPL-28 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf | |
| 06/12/2015 | SUPPL-28 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021148s028lbl.pdf | |
| 06/12/2015 | SUPPL-28 | Manufacturing (CMC) | 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-Container/Carton Labels | 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-Patient Package Insert | 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021148s027lbl.pdf | |
| 03/01/2010 | SUPPL-27 | Labeling-Package Insert | 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021148s018lbl.pdf | |
| 09/14/2007 | SUPPL-18 | Labeling-Package Insert | 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.