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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 014368

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NDA 014368 describes MEPROBAMATE, which is a drug marketed by Acella, Alembic Pharms Ltd, Barr, Chartwell Molecular, Elkins Sinn, Heather, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Lederle, Lee Km, Mallard, Mk Labs, Mylan, Nexgen Pharma Inc, Parke Davis, Perrigo, Pharmavite, Purepac Pharm, Pvt Form, Rising, Roxane, Sandoz, Scherer Labs, Solvay, Stanlabs Pharm, Sun Pharm Industries, Tablicaps, Taro, Usl Pharma, Valeant Pharm Intl, Vangard, Watson Labs, West Ward, Whiteworth Town Plsn, and Par Pharm, and is included in forty-seven NDAs. It is available from four suppliers. Additional details are available on the MEPROBAMATE profile page.

The generic ingredient in MEPROBAMATE is aspirin; meprobamate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; meprobamate profile page.

Summary for 014368

Tradename:	MEPROBAMATE
Applicant:	Mk Labs
Ingredient:	meprobamate
Patents:	0

Medical Subject Heading (MeSH) Categories for 014368

Anti-Anxiety Agents
Anticonvulsants
Hypnotics and Sedatives
Muscle Relaxants, Central

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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