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Details for New Drug Application (NDA): 084649

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NDA 084649 describes METHOCARBAMOL, which is a drug marketed by Hetero Labs Ltd Iii, Mylan Institutional, Watson Labs, Able, Sandoz, Am Therap, Purepac Pharm, Hikma Intl Pharms, Mylan, Heather, Impax Labs, Aurobindo Pharma Ltd, Pioneer Pharms, Puracap Pharm, Nylos, Inwood Labs, Roxane, Tablicaps, Ivax Sub Teva Pharms, Solvay, Marsam Pharms Llc, Upsher Smith, Lannett Holdings Inc, Austarpharma Llc, Kv Pharm, Ascot, Clonmel Hlthcare, Sun Pharm Inds, Prinston Inc, Superpharm, Vintage Pharms, Stevens J, Par Pharm, and Mcneil, and is included in sixty NDAs. It is available from fifty-three suppliers. Additional details are available on the METHOCARBAMOL profile page.

The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-one drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.

Summary for NDA: 084649

Ivax Sub Teva Pharms
Therapeutic Class:Skeletal Muscle Relaxants

Summary 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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