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Serving leading biopharmaceutical companies globally:

Cipla
Fuji
Accenture
Moodys
Citi
Covington
Julphar
US Department of Justice
AstraZeneca
McKinsey

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040445

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NDA 040445 describes METAXALONE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Epic Pharma Llc, Impax Labs Inc, Lannett Holdings Inc, Sandoz, and Sciegen Pharms Inc, and is included in seven NDAs. It is available from thirty-two suppliers. Additional details are available on the METAXALONE profile page.

The generic ingredient in METAXALONE is metaxalone. There are twenty drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
Summary for 040445
Tradename:METAXALONE
Applicant:Sandoz
Ingredient:metaxalone
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040445
Suppliers and Packaging for NDA: 040445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METAXALONE metaxalone TABLET;ORAL 040445 ANDA Eon Labs, Inc. 0185-0448 0185-0448-01 100 TABLET in 1 BOTTLE (0185-0448-01)
METAXALONE metaxalone TABLET;ORAL 040445 ANDA Eon Labs, Inc. 0185-0448 0185-0448-10 1000 TABLET in 1 BOTTLE (0185-0448-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Mar 31, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Teva
Deloitte
Medtronic
Covington
Moodys
Chinese Patent Office
Merck
Express Scripts

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