Orange Book product

HIPREX 1GM

Orange Book NDA 017681 · ESJAY PHARMA LLC · Prescription

Key facts

Proprietary name HIPREX
Active ingredients METHENAMINE HIPPURATE
Strength 1GM
Dosage form TABLET
Route ORAL
Application NDA017681
Applicant holder ESJAY PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes Reference listed drug

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Orange Book products

The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.

Source: U.S. Food and Drug Administration (FDA), Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

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