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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212623

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NDA 212623 describes METHOCARBAMOL, which is a drug marketed by Dr Reddys, Marsam Pharms Llc, Am Regent, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Monterey Pharms Llc, Navinta Llc, Pharmobedient, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Able, Aiping Pharm Inc, Am Therap, Ani Pharms, Ascot, Aurobindo Pharma Ltd, Bostal, Chartwell Molecular, Clonmel Hlthcare, Granules, Heather, Hetero Labs Ltd Iii, Hikma Intl Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Kv Pharm, Mikart, Mylan, Nylos, Oxford Pharms, Pioneer Pharms, Pointview Hldings, Prinston Inc, Puracap Pharm, Purepac Pharm, Regcon Holdings, 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-three 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 212623

Tradename:	METHOCARBAMOL
Applicant:	Pointview Hldings
Ingredient:	methocarbamol
Patents:	0

Pharmacology for NDA: 212623

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 212623

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 212623

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHOCARBAMOL	methocarbamol	TABLET;ORAL	212623	ANDA	Marlex Pharmaceuticals, Inc.	10135-722	10135-722-01	100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01)
METHOCARBAMOL	methocarbamol	TABLET;ORAL	212623	ANDA	Marlex Pharmaceuticals, Inc.	10135-722	10135-722-05	500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 30, 2021	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Apr 30, 2021	TE:	AA	RLD:	No

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