Orange Book product

ONDANSETRON 4MG

Orange Book ANDA 077717 · NESHER PHARMACEUTICALS USA LLC · Discontinued

Key facts

Proprietary name ONDANSETRON
Active ingredients ONDANSETRON
Strength 4MG
Dosage form TABLET, ORALLY DISINTEGRATING
Route ORAL
Application ANDA077717
Applicant holder NESHER PHARMACEUTICALS USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 25, 2007

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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