Orange Book product

METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL

Orange Book ANDA 040612 · FRESENIUS KABI USA LLC · Prescription

Key facts

Proprietary name METHYLPREDNISOLONE SODIUM SUCCINATE
Active ingredients METHYLPREDNISOLONE SODIUM SUCCINATE
Strength EQ 1GM BASE/VIAL
Dosage form INJECTABLE
Route INJECTION
Application ANDA040612
Applicant holder FRESENIUS KABI USA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AP
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 12, 2004

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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