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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200958

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NDA 200958 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-six 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 200958
Tradename:METHOCARBAMOL
Applicant:Austarpharma Llc
Ingredient:methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 200958
Medical Subject Heading (MeSH) Categories for 200958
Suppliers and Packaging for NDA: 200958
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL methocarbamol TABLET;ORAL 200958 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-948 N 43353-948-30
METHOCARBAMOL methocarbamol TABLET;ORAL 200958 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-948 N 43353-948-53

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 21, 2011TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength750MG
Approval Date:Oct 21, 2011TE:AARLD:No

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