Orange Book product

MAXZIDE-25 25MG;37.5MG

Orange Book NDA 019129 · AUROBINDO PHARMA USA INC · Prescription

Key facts

Proprietary name MAXZIDE-25
Active ingredients HYDROCHLOROTHIAZIDE, TRIAMTERENE
Strength 25MG;37.5MG
Dosage form TABLET
Route ORAL
Application NDA019129
Applicant holder AUROBINDO PHARMA USA INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date May 13, 1988

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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