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Details for New Drug Application (NDA): 090122

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NDA 090122 describes MEPROBAMATE, which is a drug marketed by Pvt Form, Purepac Pharm, Watson Labs, Vangard, West Ward, Mylan, Nexgen Pharma Inc, Alembic Pharms Ltd, Impax Labs, Usl Pharma, Elkins Sinn, Heather, Barr, Whiteworth Town Plsn, Roxane, Solvay, Ivax Sub Teva Pharms, Lee Km, Pharmavite, Valeant Pharm Intl, Scherer Labs, Parke Davis, Perrigo, Sandoz, Ivc Inds, Aurolife Pharma Llc, Mk Labs, Mallard, Stanlabs Pharm, Lannett, Tablicaps, Invagen Pharms, Taro, Lederle, Sun Pharm Inds, and Par Pharm, and is included in forty-seven NDAs. It is available from eight 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 NDA: 090122

Tradename:
MEPROBAMATE
Applicant:
Alembic Pharms Ltd
Ingredient:
meprobamate
Patents:0
Therapeutic Class:Anxiolytics
Formulation / Manufacturing:see details

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 Heritage Pharmaceuticals Inc. 23155-128 23155-128-01 100 TABLET in 1 BOTTLE (23155-128-01)
MEPROBAMATE
meprobamate
TABLET;ORAL 090122 ANDA Heritage Pharmaceuticals Inc. 23155-128 23155-128-03 30 TABLET in 1 BOTTLE (23155-128-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 18, 2009TE:AARLD:No

Summary for product number 002

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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