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Last Updated: June 2, 2020

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Details for New Drug Application (NDA): 084449


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NDA 084449 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Monterey Pharms Llc, Mylan Institutional, Navinta Llc, Sagent Pharms Inc, Slate, Somerset Theraps Llc, Able, Am Therap, Ani Pharms Inc, Ascot, Austarpharma Llc, Beximco Pharms Usa, Clonmel Hlthcare, Dbl Pharms, Fosun Pharma, Granules India Ltd, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Lannett Co Inc, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Watson Labs, Mcneil, Par Pharm, and Stevens J, and is included in seventy-one NDAs. It is available from fifty suppliers. Additional details are available on the METHOCARBAMOL profile page.

The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 084449
Tradename:METHOCARBAMOL
Applicant:Solvay
Ingredient:methocarbamol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084449

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength750MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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