Orange Book product

ONDANSETRON HYDROCHLORIDE EQ 4MG BASE

Orange Book ANDA 077050 · SUN PHARMACEUTICAL INDUSTRIES LTD · Discontinued

Key facts

Proprietary name ONDANSETRON HYDROCHLORIDE
Active ingredients ONDANSETRON HYDROCHLORIDE
Strength EQ 4MG BASE
Dosage form TABLET
Route ORAL
Application ANDA077050
Applicant holder SUN PHARMACEUTICAL INDUSTRIES LTD
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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