Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022325
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXTERONE AMIODARONE HYDROCHLORIDE 50MG/ML 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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