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Last Updated: February 20, 2020

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Details for New Drug Application (NDA): 205661

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NDA 205661 describes METHENAMINE HIPPURATE, which is a drug marketed by Aurobindo Pharma Ltd, Impax Labs Inc, and Micro Labs, and is included in three NDAs. It is available from three 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. Seven suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
Summary for 205661
Applicant:Aurobindo Pharma Ltd
Ingredient:methenamine hippurate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205661
Suppliers and Packaging for NDA: 205661
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METHENAMINE HIPPURATE methenamine hippurate TABLET;ORAL 205661 ANDA Aurobindo Pharma Limited 65862-782 65862-782-01 100 TABLET in 1 BOTTLE (65862-782-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Jul 5, 2016TE:ABRLD:No

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