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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 090122

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NDA 090122 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 090122

Tradename:	MEPROBAMATE
Applicant:	Alembic Pharms Ltd
Ingredient:	meprobamate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090122

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

Suppliers and Packaging for NDA: 090122

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MEPROBAMATE	meprobamate	TABLET;ORAL	090122	ANDA	Alembic Pharmaceuticals Limited	46708-019	46708-019-30	30 TABLET in 1 BOTTLE (46708-019-30)
MEPROBAMATE	meprobamate	TABLET;ORAL	090122	ANDA	Alembic Pharmaceuticals Limited	46708-019	46708-019-71	100 TABLET in 1 BOTTLE (46708-019-71)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Feb 18, 2009	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 18, 2009	TE:	AA	RLD:	No

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