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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040797

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NDA 040797 describes MEPROBAMATE, which is a drug marketed by Alembic Pharms Ltd, Aurolife Pharma Llc, Barr, Elkins Sinn, Heather, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Ivc Inds, Lannett, Lederle, Lee Km, Mallard, Mk Labs, Mylan, Nexgen Pharma Inc, Parke Davis, Perrigo, Pharmavite, Purepac Pharm, Pvt Form, 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 seven suppliers. Additional details are available on the MEPROBAMATE profile page.

The generic ingredient in MEPROBAMATE is aspirin; meprobamate. There are twenty-one drug master file entries for this compound. Additional details are available on the aspirin; meprobamate profile page.
Summary for 040797
Tradename:MEPROBAMATE
Applicant:Invagen Pharms
Ingredient:meprobamate
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040797
Suppliers and Packaging for NDA: 040797
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPROBAMATE meprobamate TABLET;ORAL 040797 ANDA Dr.Reddy's Laboratories Limited 55111-640 55111-640-10 1000 TABLET in 1 BOTTLE (55111-640-10)
MEPROBAMATE meprobamate TABLET;ORAL 040797 ANDA Dr.Reddy's Laboratories Limited 55111-640 55111-640-01 100 TABLET in 1 BOTTLE (55111-640-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 27, 2008TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 27, 2008TE:AARLD:No

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Dow
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McKesson
Julphar
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Fish and Richardson
Deloitte

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