Orange Book product

INSPRA 100MG

Orange Book NDA 021437 · UPJOHN US 2 LLC · Discontinued

Key facts

Proprietary name INSPRA
Active ingredients EPLERENONE
Strength 100MG
Dosage form TABLET
Route ORAL
Application NDA021437
Applicant holder UPJOHN US 2 LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Sep 27, 2002

At a glance

  • None 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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