Orange Book product

DAUNORUBICIN HYDROCHLORIDE EQ 50MG BASE/VIAL

Orange Book ANDA 064212 · TEVA PARENTERAL MEDICINES INC · Discontinued

Key facts

Proprietary name DAUNORUBICIN HYDROCHLORIDE
Active ingredients DAUNORUBICIN HYDROCHLORIDE
Strength EQ 50MG BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA064212
Applicant holder TEVA PARENTERAL MEDICINES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 3, 1999

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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