Orange Book product

DOXORUBICIN HYDROCHLORIDE 20MG/VIAL

Orange Book ANDA 208888 · AMNEAL EU LTD · Prescription

Key facts

Proprietary name DOXORUBICIN HYDROCHLORIDE
Active ingredients DOXORUBICIN HYDROCHLORIDE
Strength 20MG/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA208888
Applicant holder AMNEAL EU LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 17, 2017

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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