Orange Book product

CARBOPLATIN 1GM/100ML (10MG/ML)

Orange Book ANDA 206775 · ACCORD HEALTHCARE INC · Prescription

Key facts

Proprietary name CARBOPLATIN
Active ingredients CARBOPLATIN
Strength 1GM/100ML (10MG/ML)
Dosage form INJECTABLE
Route INTRAVENOUS
Application ANDA206775
Applicant holder ACCORD HEALTHCARE INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 6, 2020

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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