Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022325
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
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NEXTERONE | AMIODARONE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
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 |
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 |