Orange Book product

NYSTATIN 100,000 UNITS/GM

Orange Book ANDA 065321 · NESHER PHARMACEUTICALS USA LLC · Discontinued

Key facts

Proprietary name NYSTATIN
Active ingredients NYSTATIN
Strength 100,000 UNITS/GM
Dosage form POWDER
Route TOPICAL
Application ANDA065321
Applicant holder NESHER PHARMACEUTICALS USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Aug 18, 2006

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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