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Generated: April 24, 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, Lannett Holdings Inc, Mountain, Primus Pharms, Sandoz, and Sciegen Pharms Inc, and is included in seven NDAs. It is available from twenty-nine 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. Thirty-four suppliers are listed for this compound. Additional details are available on the metaxalone profile page.
Summary for 040445
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 N 0185-0448-01
METAXALONE metaxalone TABLET;ORAL 040445 ANDA Eon Labs, Inc. 0185-0448 N 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 hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Army
Farmers Insurance
Federal Trade Commission
Cantor Fitzgerald

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