Orange Book product

HYDRALAZINE HYDROCHLORIDE 20MG/ML

Orange Book ANDA 040373 · TEVA PARENTERAL MEDICINES INC · Discontinued

Key facts

Proprietary name HYDRALAZINE HYDROCHLORIDE
Active ingredients HYDRALAZINE HYDROCHLORIDE
Strength 20MG/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA040373
Applicant holder TEVA PARENTERAL MEDICINES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 23, 2000

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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