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Serving 500+ biopharmaceutical companies globally:

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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040486

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NDA 040486 describes METAXALONE, which is a drug marketed by Epic Pharma Llc, Sandoz, Lannett Holdings Inc, Impax Labs Inc, Actavis Labs Fl Inc, and Amneal Pharms, and is included in six NDAs. It is available from twenty-five 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-seven suppliers are listed for this compound. Additional details are available on the metaxalone profile page.

Summary for NDA: 040486

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 68387-108-30 30 TABLET in 1 BOTTLE, PLASTIC (68387-108-30)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Argus Health
McKinsey
Moodys
Mallinckrodt
Federal Trade Commission
Novartis
Fuji
Chubb

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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