Orange Book product

OXCARBAZEPINE 150MG

Orange Book ANDA 078005 · ANI PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name OXCARBAZEPINE
Active ingredients OXCARBAZEPINE
Strength 150MG
Dosage form TABLET
Route ORAL
Application ANDA078005
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Dec 11, 2007

At a glance

  • 10–99 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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