Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021426
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNITROPE SOMATROPIN 5.8MG/VIAL INJECTABLE;INJECTION Prescription None No No
OMNITROPE SOMATROPIN 1.5MG/VIAL INJECTABLE;INJECTION Prescription None No No
OMNITROPE SOMATROPIN 5MG/1.5ML INJECTABLE;INJECTION Prescription None No No
OMNITROPE SOMATROPIN 10MG/1.5ML 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
05/30/2006 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
12/13/2016 SUPPL-34 Supplement

Label is not available on this site.

07/14/2014 SUPPL-29 Supplement

Label is not available on this site.

08/29/2014 SUPPL-28 Supplement

Label is not available on this site.

08/22/2013 SUPPL-27 Supplement

Label is not available on this site.

06/18/2013 SUPPL-25 Supplement

Label is not available on this site.

04/04/2013 SUPPL-23 Supplement

Label is not available on this site.

02/15/2017 SUPPL-22 Supplement

Label is not available on this site.

04/13/2011 SUPPL-18 Supplement

Label is not available on this site.

07/22/2011 SUPPL-17 Supplement

Label is not available on this site.

08/26/2010 SUPPL-15 Supplement

Label is not available on this site.

04/23/2010 SUPPL-8 Supplement

Label is not available on this site.

04/23/2010 SUPPL-7 Supplement

Label is not available on this site.

03/25/2009 SUPPL-6 Supplement

Label is not available on this site.

08/25/2008 SUPPL-4 Supplement

Label is not available on this site.

01/16/2008 SUPPL-2 Supplement

Label is not available on this site.

OMNITROPE

There are no Therapeutic Equivalents.

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