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Generated: July 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086989

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NDA 086989 describes METHOCARBAMOL, which is a drug marketed by Marsam Pharms Llc, Watson Labs, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Luitpold Pharms Inc, Monterey Pharms Llc, Mylan Institutional, Navinta Llc, Renaissance Ssa Llc, Sagent Pharms, Somerset Theraps Llc, Able, Am Therap, 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, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Vintage Pharms, Mcneil, Par Pharm, and Stevens J, and is included in seventy NDAs. It is available from fifty-seven 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 086989
Tradename:METHOCARBAMOL
Applicant:Prinston Inc
Ingredient:methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 086989
Medical Subject Heading (MeSH) Categories for 086989
Suppliers and Packaging for NDA: 086989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL methocarbamol TABLET;ORAL 086989 ANDA KAISER FOUNDATION HOSPITALS 0179-0177 N 0179-0177-30
METHOCARBAMOL methocarbamol TABLET;ORAL 086989 ANDA Blenheim Pharmacal, Inc. 10544-773 E 10544-773-18

Profile for product number 001

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

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