Orange Book product

VANCOCIN HYDROCHLORIDE EQ 250MG BASE

Orange Book NDA 050606 · ANI PHARMACEUTICALS INC · Prescription

Key facts

Proprietary name VANCOCIN HYDROCHLORIDE
Active ingredients VANCOMYCIN HYDROCHLORIDE
Strength EQ 250MG BASE
Dosage form CAPSULE
Route ORAL
Application NDA050606
Applicant holder ANI PHARMACEUTICALS INC
Marketing status Prescription
Therapeutic equivalence (TE) code AB
Reference listed drug (RLD) Yes
Reference standard (RS) Yes
Approval date Apr 15, 1986

At a glance

  • 1–9 Marketed products with the same ingredient, strength and form
  • 1–9 Products in this application
  • Yes 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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