Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 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 is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2020 SUPPL-53 Supplement

Label is not available on this site.

08/29/2017 SUPPL-49 Supplement

Label is not available on this site.

12/13/2016 SUPPL-48 Supplement

Label is not available on this site.

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 is not available on this site.

06/12/2015 SUPPL-43 Supplement

Label is not available on this site.

01/23/2015 SUPPL-42 Supplement

Label is not available on this site.

09/25/2014 SUPPL-41 Supplement

Label is not available on this site.

05/15/2013 SUPPL-40 Supplement

Label is not available on this site.

10/14/2013 SUPPL-39 Supplement

Label is not available on this site.

02/23/2018 SUPPL-38 Supplement

Label is not available on this site.

02/23/2018 SUPPL-37 Supplement

Label is not available on this site.

05/25/2011 SUPPL-35 Supplement

Label is not available on this site.

06/12/2015 SUPPL-28 Supplement

Label is not available on this site.

03/01/2010 SUPPL-27 Supplement

Label is not available on this site.

03/10/2009 SUPPL-25 Supplement

Label is not available on this site.

10/31/2008 SUPPL-23 Supplement

Label is not available on this site.

09/14/2007 SUPPL-18 Supplement

Label is not available on this site.

09/20/2007 SUPPL-17 Supplement

Label is not available on this site.

05/31/2007 SUPPL-16 Supplement

Label is not available on this site.

02/13/2007 SUPPL-15 Supplement

Label is not available on this site.

09/01/2006 SUPPL-13 Supplement

Label is not available on this site.

11/01/2004 SUPPL-7 Supplement

Label is not available on this site.

10/01/2004 SUPPL-6 Supplement

Label is not available on this site.

04/25/2005 SUPPL-4 Supplement

Label is not available on this site.

08/16/2001 SUPPL-2 Supplement

Label is not available on this site.

03/30/2001 SUPPL-1 Supplement

Label is not available on this site.

NORDITROPIN

There are no Therapeutic Equivalents.

NORDITROPIN FLEXPRO

There are no Therapeutic Equivalents.

NORDITROPIN NORDIFLEX

There are no Therapeutic Equivalents.

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