Orange Book product

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE 32MG;25MG

Orange Book ANDA 090704 · PHARMOBEDIENT CONSULTING LLC · Prescription

Key facts

Proprietary name CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Active ingredients CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE
Strength 32MG;25MG
Dosage form TABLET
Route ORAL
Application ANDA090704
Applicant holder PHARMOBEDIENT CONSULTING LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 4, 2012

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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