Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 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 BX No No
OMNITROPE SOMATROPIN 1.5MG/VIAL INJECTABLE;INJECTION Prescription BX No No
OMNITROPE SOMATROPIN 5MG/1.5ML INJECTABLE;INJECTION Prescription BX No No
OMNITROPE SOMATROPIN 10MG/1.5ML INJECTABLE;INJECTION Prescription BX 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 Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021426s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021426Orig1s034ltr.pdf
07/14/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/29/2014 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021426Orig1s028ltr.pdf
08/22/2013 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/18/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/04/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/15/2017 SUPPL-22 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf
04/13/2011 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s018ltr.pdf
07/22/2011 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021426s017ltr.pdf
08/26/2010 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf
04/23/2010 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s008.pdf
04/23/2010 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf
03/25/2009 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021426s006ltr.pdf
08/25/2008 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf
01/16/2008 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021426s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021426s022lbl.pdf
12/13/2016 SUPPL-34 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf
12/13/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021426s034lbl.pdf
08/29/2014 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021426s028lbl.pdf
07/22/2011 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s017lbl.pdf
04/13/2011 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021426s018lbl.pdf
08/26/2010 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf
04/23/2010 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf
04/23/2010 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s007s008lbl.pdf
03/25/2009 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf
03/25/2009 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021426s006lbl.pdf
08/25/2008 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf
08/25/2008 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s004lbl.pdf
01/16/2008 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf
01/16/2008 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021426s002lbl.pdf
05/30/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021426lbl.pdf

OMNITROPE

There are no Therapeutic Equivalents.

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