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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022325
Company: BAXTER HLTHCARE

Summary Review

Products on NDA 022325

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXTERONE	AMIODARONE HYDROCHLORIDE	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
NEXTERONE	AMIODARONE HYDROCHLORIDE	150MG/100ML (1.5MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
NEXTERONE	AMIODARONE HYDROCHLORIDE	360MG/200ML (1.8MG/ML)	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022325

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022325lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022325s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325_nexterone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022325s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022325s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022325Orig1s016ltr.pdf
03/22/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022325Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022325Orig1s014ltr.pdf
11/22/2016	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022325s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022325Orig1s013ltr.pdf
10/31/2016	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/29/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/13/2015	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022325s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022325Orig1s009ltr.pdf
04/29/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/23/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/05/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/08/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/04/2013	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/12/2011	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022325s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022325s002ltr.pdf
11/16/2010	SUPPL-1	Manufacturing (CMC)	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022325s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022325s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022325Orig1s001.pdf

Labels for NDA 022325

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/07/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022325s016lbl.pdf
03/22/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022325Orig1s014lbl.pdf
11/22/2016	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022325s013lbl.pdf
03/13/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022325s009lbl.pdf
12/12/2011	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022325s002lbl.pdf
11/16/2010	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022325s001lbl.pdf
12/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022325lbl.pdf

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