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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022268
Company: NOVARTIS

Summary Review

Products on NDA 022268

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022268

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

Labels for NDA 022268

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

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