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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
UBS
Dow
Accenture
Teva
US Army
Farmers Insurance
Fuji
Harvard Business School

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203399

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NDA 203399 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-one suppliers. Additional details are available on the METAXALONE profile page.

The generic ingredient in METAXALONE is metaxalone. There are nineteen 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 203399

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 203399

Suppliers and Packaging for NDA: 203399

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METAXALONE metaxalone TABLET;ORAL 203399 ANDA Blenheim Pharmacal, Inc. 10544-144 10544-144-12 12 TABLET in 1 BOTTLE (10544-144-12)
METAXALONE metaxalone TABLET;ORAL 203399 ANDA Blenheim Pharmacal, Inc. 10544-144 10544-144-20 20 TABLET in 1 BOTTLE (10544-144-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jun 21, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

UBS
QuintilesIMS
Moodys
Deloitte
Dow
Fuji
Teva
Colorcon
Harvard Business School
Cipla

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