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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076411

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NDA 076411 describes METHENAMINE HIPPURATE, which is a drug marketed by Aurobindo Pharma Ltd and Impax Labs Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the METHENAMINE HIPPURATE profile page.

The generic ingredient in METHENAMINE HIPPURATE is methenamine hippurate. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
Summary for 076411
Applicant:Impax Labs Inc
Ingredient:methenamine hippurate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076411
Suppliers and Packaging for NDA: 076411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHENAMINE HIPPURATE methenamine hippurate TABLET;ORAL 076411 ANDA Impax Generics 0115-1754 N 0115-1754-01
METHENAMINE HIPPURATE methenamine hippurate TABLET;ORAL 076411 ANDA CorePharma, LLC 64720-139 N 64720-139-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jun 20, 2003TE:ABRLD:No

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