Orange Book product

AMLODIPINE BESYLATE EQ 2.5MG BASE

Orange Book ANDA 078131 · PURACAP PHARMACEUTICAL LLC · Discontinued

Key facts

Proprietary name AMLODIPINE BESYLATE
Active ingredients AMLODIPINE BESYLATE
Strength EQ 2.5MG BASE
Dosage form TABLET
Route ORAL
Application ANDA078131
Applicant holder PURACAP PHARMACEUTICAL LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 4, 2007

At a glance

  • 10–99 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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