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Generated: April 26, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the artemether; lumefantrine profile page.
Summary for 022268
Ingredient:artemether; lumefantrine
Formulation / Manufacturing:see details
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 N 0078-0568-45
COARTEM artemether; lumefantrine TABLET;ORAL 022268 NDA Central Texas Community Health Centers 76413-154 N 76413-154-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;120MG
Approval Date:Apr 7, 2009TE:RLD:Yes

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