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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Julphar
Chubb
Medtronic
UBS
US Army
Moodys
McKesson
Cerilliant
Covington

Generated: June 23, 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 Epic Pharma Llc, Sandoz, Lannett Holdings Inc, Impax Labs Inc, and Amneal Pharms, and is included in five NDAs. It is available from twenty-four 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. Thirty-six suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 203399

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 10544-144-09 9 TABLET in 1 BOTTLE (10544-144-09)
METAXALONE
metaxalone
TABLET;ORAL 203399 ANDA Blenheim Pharmacal, Inc. 10544-144 10544-144-12 12 TABLET in 1 BOTTLE (10544-144-12)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
US Department of Justice
Harvard Business School
UBS
Julphar
Medtronic
Mallinckrodt
Deloitte
Healthtrust
Daiichi Sankyo

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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