Orange Book product

VANCOMYCIN HYDROCHLORIDE EQ 250MG BASE

Orange Book ANDA 210729 · ORIENT PHARMA CO LTD · Prescription

Key facts

Proprietary name VANCOMYCIN HYDROCHLORIDE
Active ingredients VANCOMYCIN HYDROCHLORIDE
Strength EQ 250MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA210729
Applicant holder ORIENT PHARMA CO LTD
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Apr 29, 2019

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