Orange Book product

ACETAZOLAMIDE 500MG

Orange Book ANDA 207659 · ACCORD HEALTHCARE INC · Prescription

Key facts

Proprietary name ACETAZOLAMIDE
Active ingredients ACETAZOLAMIDE
Strength 500MG
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Application ANDA207659
Applicant holder ACCORD HEALTHCARE INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Oct 18, 2018

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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