Orange Book product

TOLMETIN SODIUM EQ 400MG BASE

Orange Book ANDA 073393 · RISING PHARMA HOLDINGS INC · Prescription

Key facts

Proprietary name TOLMETIN SODIUM
Active ingredients TOLMETIN SODIUM
Strength EQ 400MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA073393
Applicant holder RISING PHARMA HOLDINGS INC
Marketing status Prescription
Reference listed drug (RLD) No
Reference standard (RS) Yes
Approval date May 27, 1993

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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