Orange Book product

MYCOPHENOLATE SODIUM EQ 180MG BASE

Orange Book ANDA 216637 · FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD · Prescription

Key facts

Proprietary name MYCOPHENOLATE SODIUM
Active ingredients MYCOPHENOLATE SODIUM
Strength EQ 180MG BASE
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Application ANDA216637
Applicant holder FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 29, 2024

At a glance

  • 10–99 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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