Orange Book product

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 100MG;50MG

Orange Book ANDA 085440 · WATSON LABORATORIES INC · Discontinued

Key facts

Proprietary name HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE
Strength 100MG;50MG
Dosage form CAPSULE
Route ORAL
Application ANDA085440
Applicant holder WATSON LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 4, 1982

At a glance

  • None 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)

Browse all Orange Book products