Orange Book product

DIOVAN HCT 25MG;320MG

Orange Book NDA 020818 · NOVARTIS PHARMACEUTICALS CORP · Prescription

Key facts

Proprietary name DIOVAN HCT
Active ingredients HYDROCHLOROTHIAZIDE, VALSARTAN
Strength 25MG;320MG
Dosage form TABLET
Route ORAL
Application NDA020818
Applicant holder NOVARTIS PHARMACEUTICALS CORP
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Apr 28, 2006

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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