Orange Book product

APRESAZIDE 25MG;25MG

Orange Book ANDA 084735 · NOVARTIS PHARMACEUTICALS CORP · Discontinued

Key facts

Proprietary name APRESAZIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE
Strength 25MG;25MG
Dosage form CAPSULE
Route ORAL
Application ANDA084735
Applicant holder NOVARTIS PHARMACEUTICALS CORP
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jan 1, 1982

At a glance

  • None 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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