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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Fish and Richardson
McKinsey
Harvard Business School
AstraZeneca
Covington
Colorcon
Argus Health
Moodys

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085159

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NDA 085159 describes METHOCARBAMOL, which is a drug marketed by Marsam Pharms Llc, Watson Labs, Aurobindo Pharma Ltd, Luitpold Pharms Inc, Monterey Pharms Llc, Mylan Institutional, Renaissance Ssa Llc, Sagent Pharms, Somerset Theraps Llc, Able, Am Therap, Ascot, Atlas Pharms Llc, Austarpharma Llc, Beximco Pharms Usa, Clonmel Hlthcare, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Lannett Holdings 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 sixty-seven 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 085159
Tradename:METHOCARBAMOL
Applicant:Hikma Intl Pharms
Ingredient:methocarbamol
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 085159
Medical Subject Heading (MeSH) Categories for 085159
Suppliers and Packaging for NDA: 085159
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL methocarbamol TABLET;ORAL 085159 ANDA West-Ward Pharmaceuticals Corp 0143-1290 0143-1290-10 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1290-10)
METHOCARBAMOL methocarbamol TABLET;ORAL 085159 ANDA West-Ward Pharmaceuticals Corp 0143-1290 0143-1290-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-1290-05)

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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Covington
Deloitte
QuintilesIMS
Express Scripts
Mallinckrodt
Medtronic
Queensland Health
Argus Health

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