Orange Book product

NYSTATIN 500,000 UNITS

Orange Book ANDA 062524 · CHARTWELL RX SCIENCES LLC · Discontinued

Key facts

Proprietary name NYSTATIN
Active ingredients NYSTATIN
Strength 500,000 UNITS
Dosage form TABLET
Route ORAL
Application ANDA062524
Applicant holder CHARTWELL RX SCIENCES LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Nov 26, 1985

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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