Orange Book product

CYCLOPHOSPHAMIDE 2GM/VIAL

Orange Book ANDA 218632 · HAINAN POLY PHARM CO LTD · Prescription

Key facts

Proprietary name CYCLOPHOSPHAMIDE
Active ingredients CYCLOPHOSPHAMIDE
Strength 2GM/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA218632
Applicant holder HAINAN POLY PHARM CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 26, 2024

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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