Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203441
Company: NPS PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GATTEX KIT TEDUGLUTIDE RECOMBINANT 5MG/VIAL POWDER;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203441Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203441Orig1s000ltr_replacement.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203441Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2019 SUPPL-13 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203441s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203441Orig1s013ltr.pdf
12/18/2018 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203441s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203441Orig1s012Ltr.pdf
03/21/2017 SUPPL-10 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203441Orig1s010ltr.pdf
05/27/2016 SUPPL-8 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203441Orig1s008ltr.pdf
03/30/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/05/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/26/2014 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203441Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203441Orig1s002.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203441s013lbl.pdf
12/18/2018 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203441s012lbl.pdf
06/26/2014 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203441s002lbl.pdf
12/21/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203441Orig1s000lbl.pdf

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