Orange Book product

DEXAMETHASONE 0.5MG/5ML **Federal Register determination that product was…

Orange Book ANDA 088254 · PHARMOBEDIENT CONSULTING · Discontinued

Key facts

Proprietary name DEXAMETHASONE
Active ingredients DEXAMETHASONE
Strength 0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form ELIXIR
Route ORAL
Application ANDA088254
Applicant holder PHARMOBEDIENT CONSULTING
Marketing status Discontinued
Reference listed drug (RLD) Yes
Reference standard (RS) No
Approval date Jul 27, 1983

At a glance

  • None Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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