Orange Book product

METHYLPREDNISOLONE 4MG

Orange Book ANDA 040189 · JUBILANT CADISTA PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name METHYLPREDNISOLONE
Active ingredients METHYLPREDNISOLONE
Strength 4MG
Dosage form TABLET
Route ORAL
Application ANDA040189
Applicant holder JUBILANT CADISTA PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 31, 1997

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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