Orange Book product

VANCOMYCIN HYDROCHLORIDE EQ 125MG BASE

Orange Book ANDA 065453 · FRESENIUS KABI USA LLC · Discontinued

Key facts

Proprietary name VANCOMYCIN HYDROCHLORIDE
Active ingredients VANCOMYCIN HYDROCHLORIDE
Strength EQ 125MG BASE
Dosage form CAPSULE
Route ORAL
Application ANDA065453
Applicant holder FRESENIUS KABI USA LLC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date Jun 18, 2012

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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