Orange Book product

NILSTAT 100,000 UNITS

Orange Book ANDA 061325 · LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO · Discontinued

Key facts

Proprietary name NILSTAT
Active ingredients NYSTATIN
Strength 100,000 UNITS
Dosage form TABLET
Route VAGINAL
Application ANDA061325
Applicant holder LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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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