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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021321
Company: BAXTER HLTHCARE

Products on NDA 021321

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXTRANEAL	ICODEXTRIN	7.5GM/100ML	SOLUTION;INTRAPERITONEAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021321

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2002	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21321ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21321_Extraneal.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2024	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021321s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021321Orig1s038ltr.pdf
12/04/2019	SUPPL-37	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021321s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021321Orig1s037ltr.pdf
10/24/2016	SUPPL-35	REMS-Assessment	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s035ltr.pdf
12/16/2016	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021321s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021321Orig1s034ltr.pdf
08/01/2016	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/16/2015	SUPPL-32	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021321Orig1s032ltr.pdf
02/04/2014	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
02/25/2014	SUPPL-29	REMS-Assessment	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s029ltr.pdf
12/09/2014	SUPPL-28	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021321Orig1s028ltr.pdf
04/26/2013	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/09/2011	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf
03/09/2011	SUPPL-20	REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021321s020,s021ltr.pdf
01/29/2009	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s018ltr.pdf
04/07/2009	SUPPL-17	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021321s017ltr.pdf
02/23/2007	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021321s013ltr.pdf
12/17/2004	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21321s010ltr.pdf
05/24/2005	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s009ltr.pdf
05/24/2005	SUPPL-8	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021321s008ltr.pdf

Labels for NDA 021321

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/22/2024	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021321s038lbl.pdf
12/04/2019	SUPPL-37	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021321s037lbl.pdf
12/16/2016	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021321s034lbl.pdf
10/16/2015	SUPPL-32	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf
03/09/2011	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011	SUPPL-21	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
03/09/2011	SUPPL-20	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf
04/07/2009	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021321s017lbl.pdf
12/17/2004	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21321s010lbl.pdf
12/20/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf

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