Orange Book product

ZONISAMIDE 100MG

Orange Book ANDA 077651 · GLENMARK PHARMACEUTICALS INC USA · Prescription

Key facts

Proprietary name ZONISAMIDE
Active ingredients ZONISAMIDE
Strength 100MG
Dosage form CAPSULE
Route ORAL
Application ANDA077651
Applicant holder GLENMARK PHARMACEUTICALS INC USA
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jan 30, 2006

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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