Orange Book product

SPIRONOLACTONE 25MG

Orange Book ANDA 087687 · ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC · Discontinued

Key facts

Proprietary name SPIRONOLACTONE
Active ingredients SPIRONOLACTONE
Strength 25MG
Dosage form TABLET
Route ORAL
Application ANDA087687
Applicant holder ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 20, 1982

At a glance

  • 10–99 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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