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Details for New Drug Application (NDA): 083605

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NDA 083605 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, Monterey Pharms Llc, 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-one NDAs. It is available from fifty-four 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: 083605

Tradename:
METHOCARBAMOL
Applicant:
Watson Labs
Ingredient:
methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

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


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