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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215065

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NDA 215065 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 215065

Tradename:	METHOCARBAMOL
Applicant:	Baxter Hlthcare Corp
Ingredient:	methocarbamol
Patents:	0

Pharmacology for NDA: 215065

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 215065

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 215065

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHOCARBAMOL	methocarbamol	SOLUTION;IM-IV	215065	ANDA	Baxter Healthcare Corporation	36000-302	36000-302-25	25 VIAL in 1 CARTON (36000-302-25) / 10 mL in 1 VIAL (36000-302-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;IM-IV			Strength	1GM/10ML (100MG/ML)
Approval Date:	Jul 14, 2022	TE:		RLD:	No

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