Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Covington
Harvard Business School
UBS
Daiichi Sankyo
US Department of Justice
Express Scripts
Medtronic
Dow

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011011

« Back to Dashboard

NDA 011011 describes ROBAXIN-750, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ROBAXIN-750 profile page.

The generic ingredient in ROBAXIN-750 is methocarbamol. There are twenty-seven drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the methocarbamol profile page.
Summary for 011011
Tradename:ROBAXIN-750
Applicant:Auxilium Pharms Llc
Ingredient:methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 011011
Medical Subject Heading (MeSH) Categories for 011011
Suppliers and Packaging for NDA: 011011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROBAXIN methocarbamol TABLET;ORAL 011011 NDA Endo Pharmaceuticals, Inc. 52244-429 N 52244-429-10
ROBAXIN methocarbamol TABLET;ORAL 011011 NDA Endo Pharmaceuticals, Inc. 52244-449 N 52244-449-10

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Cantor Fitzgerald
Johnson and Johnson
McKesson
McKinsey
Chinese Patent Office
Mallinckrodt
Argus Health
AstraZeneca

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.