Orange Book product

VANCOLED EQ 2GM BASE/VIAL **Federal Register determination that…

Orange Book ANDA 062682 · HIKMA PHARMACEUTICALS USA INC · Discontinued

Key facts

Proprietary name VANCOLED
Active ingredients VANCOMYCIN HYDROCHLORIDE
Strength EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form INJECTABLE
Route INJECTION
Application ANDA062682
Applicant holder HIKMA PHARMACEUTICALS USA INC
Marketing status Discontinued
Reference listed drug (RLD) No
Reference standard (RS) No
Approval date May 11, 1988

At a glance

  • None 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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