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Generated: December 11, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204404

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NDA 204404 describes METHOCARBAMOL, which is a drug marketed by Marsam Pharms Llc, Watson Labs, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, 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, Oxford Pharms, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Mcneil, Par Pharm, and Stevens J, and is included in seventy-one NDAs. It is available from sixty-two suppliers. Additional details are available on the METHOCARBAMOL profile page.

The generic ingredient in METHOCARBAMOL is aspirin; methocarbamol. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; methocarbamol profile page.
Summary for 204404
Tradename:METHOCARBAMOL
Applicant:Mylan Institutional
Ingredient:methocarbamol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204404
Medical Subject Heading (MeSH) Categories for 204404
Suppliers and Packaging for NDA: 204404
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHOCARBAMOL methocarbamol SOLUTION;IM-IV 204404 ANDA General Injectables and Vaccines, Inc. 52584-073 52584-073-00 1 VIAL, SINGLE-DOSE in 1 BAG (52584-073-00) > 10 mL in 1 VIAL, SINGLE-DOSE
METHOCARBAMOL methocarbamol SOLUTION;IM-IV 204404 ANDA Mylan Institutional LLC 67457-273 67457-273-10 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-273-10) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-273-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IM-IVStrength1GM/10ML (100MG/ML)
Approval Date:Dec 5, 2014TE:APRLD:No

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