Orange Book product

ZARONTIN 250MG/5ML

Orange Book ANDA 080258 · PARKE-DAVIS DIVISION OF PFIZER INC · Prescription

Key facts

Proprietary name ZARONTIN
Active ingredients ETHOSUXIMIDE
Strength 250MG/5ML
Dosage form SYRUP
Route ORAL
Application ANDA080258
Applicant holder PARKE-DAVIS DIVISION OF PFIZER INC
Marketing status Prescription
Therapeutic equivalence (TE) code AA
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Jan 1, 1982

At a glance

  • 1–9 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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