Details for New Drug Application (NDA): 022268

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NDA 022268 describes COARTEM, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the COARTEM profile page.

The generic ingredient in COARTEM is artemether; lumefantrine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the artemether; lumefantrine profile page.

Summary for 022268

Tradename:	COARTEM
Applicant:	Novartis
Ingredient:	artemether; lumefantrine
Patents:	0

Pharmacology for NDA: 022268

Suppliers and Packaging for NDA: 022268

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COARTEM	artemether; lumefantrine	TABLET;ORAL	022268	NDA	Novartis Pharmaceuticals Corporation	0078-0568	0078-0568-45	24 TABLET in 1 BOTTLE (0078-0568-45)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG;120MG
Approval Date:	Apr 7, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022268

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	COARTEM	artemether; lumefantrine	TABLET;ORAL	022268-001	Apr 7, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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