Orange Book product

DOXORUBICIN HYDROCHLORIDE 10MG/VIAL

Orange Book ANDA 063097 · PHARMACHEMIE BV · Discontinued

Key facts

Proprietary name DOXORUBICIN HYDROCHLORIDE
Active ingredients DOXORUBICIN HYDROCHLORIDE
Strength 10MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA063097
Applicant holder PHARMACHEMIE BV
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 21, 1990

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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