Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022268
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COARTEM | ARTEMETHER; LUMEFANTRINE | 20MG;120MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/07/2009 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022268lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022268s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022268s000_SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/05/2019 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022268s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022268Orig1s021ltr.pdf | |
01/08/2018 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022268s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022268Orig1s019ltr.pdf | |
06/01/2016 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/06/2016 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/02/2015 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/19/2015 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022268s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022268Orig1s012ltr.pdf | |
01/20/2015 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/12/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/06/2014 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/17/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/2013 | 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. |
||
04/03/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/2013 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022268s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022268Orig1s004ltr.pdf | |
08/06/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022268s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022268Orig1s003ltr.pdf | |
02/17/2010 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022268s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022268s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/05/2019 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022268s021lbl.pdf | |
01/08/2018 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022268s019lbl.pdf | |
03/19/2015 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022268s012lbl.pdf | |
04/29/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022268s004lbl.pdf | |
08/06/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022268s003lbl.pdf | |
02/17/2010 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022268s001lbl.pdf | |
04/07/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022268lbl.pdf |