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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

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, Elkins Sinn, Heather, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Lannett, 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
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090122
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 18, 2009TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 18, 2009TE:AARLD:No

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