Orange Book product

GALANTAMINE HYDROBROMIDE EQ 8MG BASE

Orange Book ANDA 090957 · AUROBINDO PHARMA LIMITED · Prescription

Key facts

Proprietary name GALANTAMINE HYDROBROMIDE
Active ingredients GALANTAMINE HYDROBROMIDE
Strength EQ 8MG BASE
Dosage form TABLET
Route ORAL
Application ANDA090957
Applicant holder AUROBINDO PHARMA LIMITED
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Mar 29, 2011

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