Orange Book product

DILANTIN-30 30MG/5ML

Orange Book NDA 008762 · VIATRIS SPECIALTY LLC · Discontinued

Key facts

Proprietary name DILANTIN-30
Active ingredients PHENYTOIN
Strength 30MG/5ML
Dosage form SUSPENSION
Route ORAL
Application NDA008762
Applicant holder VIATRIS SPECIALTY LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 1, 1982

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)

Browse all Orange Book products