Orange Book product

MYCOPHENOLATE MOFETIL 500MG

Orange Book ANDA 204076 · ZHEJIANG HISUN PHARMACEUTICAL CO LTD · Prescription

Key facts

Proprietary name MYCOPHENOLATE MOFETIL
Active ingredients MYCOPHENOLATE MOFETIL
Strength 500MG
Dosage form TABLET
Route ORAL
Application ANDA204076
Applicant holder ZHEJIANG HISUN PHARMACEUTICAL CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 16, 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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