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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 200998

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NDA 200998 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 200998

Tradename:	MEPROBAMATE
Applicant:	Taro
Ingredient:	meprobamate
Patents:	0

Medical Subject Heading (MeSH) Categories for 200998

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

Suppliers and Packaging for NDA: 200998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEPROBAMATE	meprobamate	TABLET;ORAL	200998	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-4147	51672-4147-1	100 TABLET in 1 BOTTLE (51672-4147-1)
MEPROBAMATE	meprobamate	TABLET;ORAL	200998	ANDA	Taro Pharmaceuticals U.S.A., Inc.	51672-4147	51672-4147-3	1000 TABLET in 1 BOTTLE (51672-4147-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 23, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 23, 2011	TE:		RLD:	No

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