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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 NDA: 022268

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
artemether; lumefantrine
TABLET;ORAL 022268 NDA Novartis Pharmaceuticals Corporation 0078-0568 0078-0568-45 24 TABLET in 1 BOTTLE (0078-0568-45)
artemether; lumefantrine
TABLET;ORAL 022268 NDA Department of State Health Services, Pharmacy Branch 55695-020 55695-020-00 24 TABLET in 1 BOTTLE (55695-020-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;120MG
Approval Date:Apr 7, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 7, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 022268

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
artemether; lumefantrine
TABLET;ORAL022268-001Apr 7, 20095,677,331<disabled>
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