Orange Book product

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 20MG;25MG

Orange Book ANDA 076342 · ANI PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Active ingredients BENAZEPRIL HYDROCHLORIDE, HYDROCHLOROTHIAZIDE
Strength 20MG;25MG
Dosage form TABLET
Route ORAL
Application ANDA076342
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 11, 2004

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • No 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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