Orange Book product

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER EQ 0.64MG BASE/ML

Orange Book ANDA 076978 · HOSPIRA INC · Discontinued

Key facts

Proprietary name ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
Active ingredients ONDANSETRON HYDROCHLORIDE
Strength EQ 0.64MG BASE/ML
Dosage form INJECTABLE
Route INJECTION
Application ANDA076978
Applicant holder HOSPIRA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Feb 26, 2007

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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