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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 209331

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NDA 209331 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. Additional details are available on the aspirin; methocarbamol profile page.

Summary for 209331

Tradename:	METHOCARBAMOL
Applicant:	Fresenius Kabi Usa
Ingredient:	methocarbamol
Patents:	0

Pharmacology for NDA: 209331

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 209331

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 209331

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHOCARBAMOL	methocarbamol	SOLUTION;IM-IV	209331	ANDA	Fresenius Kabi USA, LLC	63323-778	63323-778-10	25 VIAL in 1 CARTON (63323-778-10) / 10 mL in 1 VIAL (63323-778-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IM-IV			Strength	1GM/10ML (100MG/ML)
Approval Date:	Apr 17, 2018	TE:	AP	RLD:	No

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