`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
`
`Label and Approval History
`
`Drug Name(s)
`
`GATTEX KIT
`
`FDA Application No.
`
`(NDA) 203441
`
`Active Ingredient(s)
`
`TEDUGLUTIDE RECOMBINANT
`
`Company
`
`NPS PHARMS INC
`
`Go to Approval History
`
`Label Information
`
`What information does a label include?
`Note: Not all labels are available in electronic format from FDA.
`
`The supplement type of the 10/05/2015 approval does not usually require new labeling.
`
`View the label approved on 06/26/2014 (PDF) for NDA no. 203441
`
`To see if other previously-approved labels are available on this site, go to the "Approval History" section
`of this page. Older labels are for historical information only and should not be used for clinical
`purposes.
`
`Page 1
`
`
`
`Approval History
`NDA 203441
`
`Note: Not all reviews are available in electronic format from FDA.
`Older labels are for historical information only, and should not be used for clinical purposes.
`Approval dates can only be verified from 1984 to the present.
`
`Click on a column header to re-sort the table:
`
` Download data
`
`Action
`Date
`
`Supplement
`Number
`
`Approval
`Type
`
`Letters,
`Reviews,
`Labels,
`Patient
`Package
`Insert
`
`10/05/2015 006
`
`05/18/2015 005
`
`01/05/2015 004
`
`06/26/2014 002
`
`Manufacturing Change or
`Addition
`
`Manufacturing Change or
`Addition
`
`Manufacturing Change or
`Addition
`
`
`
`
`
`
`
`Efficacy Supplement with
`Clinical Data to Support
`
`Label (PDF)
`Letter (PDF)
`
`12/21/2012 000
`
`Approval
`
`Label (PDF)
`Letter (PDF)
`REMS
`Review
`Summary
`Review (PDF)
`
`
`Note
`
`This supplement type does
`not usually require new labeling.
`
`This supplement type does
`not usually require new labeling.
`
`This supplement type does
`not usually require new labeling.
`
`
`
`
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading
`Viewers and Players
`
`There are no Therapeutic Equivalents
`
`Medication Guide
`
`REMS
`
`Page 2
`
`
`
`-
`
`Disclaimer
`
`Page 3
`
`Page 3
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