Orange Book product

ACETAZOLAMIDE 250MG

Orange Book ANDA 217197 · NE RX PHARMA LLC · Prescription

Key facts

Proprietary name ACETAZOLAMIDE
Active ingredients ACETAZOLAMIDE
Strength 250MG
Dosage form TABLET
Route ORAL
Application ANDA217197
Applicant holder NE RX PHARMA LLC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 9, 2023

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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