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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Teva
AstraZeneca
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Novartis
Moodys
Queensland Health
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Cipla
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Generated: June 27, 2017

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 NDA: 022268

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0078-0568-45 24 TABLET in 1 BOTTLE (0078-0568-45)
COARTEM
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

Expired Orange Book Patents for NDA: 022268

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
COARTEM
artemether; lumefantrine
TABLET;ORAL022268-001Apr 7, 20095,677,331► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Novartis
Cipla
Colorcon
Johnson and Johnson
UBS
Medtronic
Baxter
Citi
Fuji
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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