Orange Book product

METHAZOLAMIDE 50MG

Orange Book ANDA 040001 · ANI PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name METHAZOLAMIDE
Active ingredients METHAZOLAMIDE
Strength 50MG
Dosage form TABLET
Route ORAL
Application ANDA040001
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 30, 1993

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)

Browse all Orange Book products