Orange Book product

PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML

Orange Book ANDA 076913 · PHARMACEUTICAL ASSOC INC · Prescription

Key facts

Proprietary name PREDNISOLONE SODIUM PHOSPHATE
Active ingredients PREDNISOLONE SODIUM PHOSPHATE
Strength EQ 15MG BASE/5ML
Dosage form SOLUTION
Route ORAL
Application ANDA076913
Applicant holder PHARMACEUTICAL ASSOC INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date Apr 25, 2005

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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