Orange Book product

HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 100MG;50MG

Orange Book ANDA 087609 · SOLVAY PHARMACEUTICALS · Discontinued

Key facts

Proprietary name HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE
Strength 100MG;50MG
Dosage form CAPSULE
Route ORAL
Application ANDA087609
Applicant holder SOLVAY PHARMACEUTICALS
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 8, 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)

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