Orange Book product

CYCLOPHOSPHAMIDE 50MG

Orange Book ANDA 040032 · ROXANE LABORATORIES INC · Discontinued

Key facts

Proprietary name CYCLOPHOSPHAMIDE
Active ingredients CYCLOPHOSPHAMIDE
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA040032
Applicant holder ROXANE LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 17, 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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