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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 083494


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NDA 083494 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 083494
Tradename:MEPROBAMATE
Applicant:Tablicaps
Ingredient:meprobamate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 083494

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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