Orange Book product

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG

Orange Book ANDA 077375 · RISING PHARMA HOLDINGS INC · Discontinued

Key facts

Proprietary name AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Active ingredients AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDE
Strength EQ 5MG BASE;10MG
Dosage form CAPSULE
Route ORAL
Application ANDA077375
Applicant holder RISING PHARMA HOLDINGS INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 21, 2010

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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