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Last Updated: June 24, 2021

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Details for New Drug Application (NDA): 016151

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NDA 016151 describes UREX, which is a drug marketed by Cnty Line Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the UREX profile page.

The generic ingredient in UREX is methenamine hippurate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.
Summary for 016151
Applicant:Cnty Line Pharms
Ingredient:methenamine hippurate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 016151
Suppliers and Packaging for NDA: 016151
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UREX methenamine hippurate TABLET;ORAL 016151 NDA County Line Pharmaceuticals, LLC 43199-020 43199-020-01 100 TABLET in 1 BOTTLE (43199-020-01)
UREX methenamine hippurate TABLET;ORAL 016151 NDA Alvogen Inc. 47781-577 47781-577-01 100 TABLET in 1 BOTTLE (47781-577-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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