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Serving leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
McKinsey
Colorcon
Johnson and Johnson
AstraZeneca
McKesson
Medtronic
Citi
Deloitte

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040486

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NDA 040486 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 040486
Tradename:METAXALONE
Applicant:Impax Labs Inc
Ingredient:metaxalone
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 040486
Suppliers and Packaging for NDA: 040486
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METAXALONE metaxalone TABLET;ORAL 040486 ANDA CorePharma, LLC 64720-126 64720-126-10 100 TABLET in 1 BOTTLE (64720-126-10)
METAXALONE metaxalone TABLET;ORAL 040486 ANDA Keltman Pharmaceuticals Inc. 68387-108 68387-108-90 90 TABLET in 1 BOTTLE, PLASTIC (68387-108-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 27, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Healthtrust
Daiichi Sankyo
US Army
Teva
Dow
Fuji
Harvard Business School
Colorcon

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