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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 085718

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NDA 085718 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Monterey Pharms Llc, Navinta Llc, Norvium Bioscience, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Able, Allied, Am Therap, Ani Pharms, Ascot, Aurobindo Pharma Ltd, Beximco Pharms Usa, Chartwell Molecular, Clonmel Hlthcare, Fosun Pharma, Granules, Hangzhou Binjiang, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Hlthcare, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Mikart, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Prinston Inc, Puracap Pharm, Purepac Pharm, Roxane, Sandoz, Solvay, Sun Pharm Industries, Superpharm, Tablicaps, Upsher Smith, Watson Labs, Mcneil, Par Pharm, and Stevens J, and is included in seventy-four NDAs. It is available from sixty-one 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. One supplier is listed for this compound. Additional details are available on the aspirin; methocarbamol profile page.

Summary for 085718

Tradename:	METHOCARBAMOL
Applicant:	Purepac Pharm
Ingredient:	methocarbamol
Patents:	0

Medical Subject Heading (MeSH) Categories for 085718

Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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