Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022268
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English