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Generated: December 16, 2018

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Details for New Drug Application (NDA): 017681

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NDA 017681 describes HIPREX, which is a drug marketed by Us Pharm Holdings and is included in one NDA. It is available from three suppliers. Additional details are available on the HIPREX profile page.

The generic ingredient in HIPREX 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 017681
Tradename:HIPREX
Applicant:Us Pharm Holdings
Ingredient:methenamine hippurate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017681
Suppliers and Packaging for NDA: 017681
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HIPREX methenamine hippurate TABLET;ORAL 017681 NDA Winthrop U.S. 0955-1037 0955-1037-10 100 TABLET in 1 BOTTLE (0955-1037-10)
HIPREX methenamine hippurate TABLET;ORAL 017681 NDA Validus Pharmaceuticals LLC 30698-277 30698-277-01 100 TABLET in 1 BOTTLE (30698-277-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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