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Generated: April 30, 2017

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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 four suppliers. Additional details are available on the HIPREX profile page.

The generic ingredient in HIPREX is methenamine hippurate. There are nine 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 NDA: 017681

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 017681

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
methenamine hippurate
TABLET;ORAL 017681 NDA Sanofi-Aventis U.S. LLC 0068-0277 0068-0277-61 100 TABLET in 1 BOTTLE (0068-0277-61)
methenamine hippurate
TABLET;ORAL 017681 NDA Winthrop U.S. 0955-1037 0955-1037-10 100 TABLET in 1 BOTTLE (0955-1037-10)

Summary 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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