Orange Book product

HYDROCHLOROTHIAZIDE 12.5MG

Orange Book ANDA 040857 · SUN PHARMACEUTICAL INDUSTRIES INC · Discontinued

Key facts

Proprietary name HYDROCHLOROTHIAZIDE
Active ingredients HYDROCHLOROTHIAZIDE
Strength 12.5MG
Dosage form TABLET
Route ORAL
Application ANDA040857
Applicant holder SUN PHARMACEUTICAL INDUSTRIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 30, 2008

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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