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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203441
Company: TAKEDA PHARMS USA

Medication Guide

REMS

Summary Review

Products on NDA 203441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GATTEX KIT	TEDUGLUTIDE	5MG/VIAL	POWDER;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203441

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
02/21/2024	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203441s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203441Orig1s021ltr.pdf
02/11/2021	SUPPL-20	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203441Orig1s020ltr.pdf
07/14/2020	SUPPL-19	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203441Orig1s019ltr.pdf
01/29/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203441Orig1s018ltr.pdf
01/24/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203441Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203441Orig1s016ltr.pdf
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

Labels for NDA 203441

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2024	SUPPL-21	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203441s021lbl.pdf
01/24/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203441Orig1s016lbl.pdf
01/29/2021	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441Orig1s016lbl.pdf
01/29/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203441Orig1s016lbl.pdf
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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